Rogero v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 11-770V

(To be published)

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

*

HEATHER ROGERO and *

WALTER A. ROGERO, II, Friends of * Filed: September 1, 2017

W.R., a minor, *

*

Petitioners, *

* Autism; Vaccine Act Entitlement;

v. * Causation-in-fact; Pediarix; Hib;

* Prevnar; Seborrheic Dermatitis;

SECRETARY OF HEALTH AND * Encephalopathy; Autoimmune

HUMAN SERVICES, * Illnesses; Aluminum Adjuvant

*

Respondent. *

*

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

Clifford J. Shoemaker, Vienna, VA, Virginia, for Petitioners.

Voris Johnson, Department of Justice, Washington, D.C., for Respondent.

DECISION

HASTINGS, Special Master.

This is an action in which the Petitioners, Heather and Walter Rogero II, request

compensation under the National Vaccine Injury Compensation Program (hereinafter “the

Program”1), on account of their minor son (“W.R.”). Petitioners allege that a series of

vaccinations administered to W.R. on November 19, 2008, January 19, 2009, April 27, 2009,

August 1, 2009, September 24, 2009, and May 4, 2010, caused a variety of neurodevelopmental

and immunological injuries. Among W.R.’s neurodevelopmental conditions, he has been

diagnosed with an autism spectrum disorder (ASD). For the reasons set forth below, I conclude

that Petitioners are not entitled to an award.2

1

The applicable statutory provisions defining the Program are found at 42 U.S.C. § 300aa-

10 et seq. (2012 ed.). Hereinafter, for ease of citation, all "§" references will be to 42 U.S.C.

(2012 ed.). The statutory provisions defining the Program are also sometimes referred to as the

“Vaccine Act.”

2

Although I have considered the entire record, including the voluminous medical records

and medical literature, in arriving at my decision, I will only discuss evidence specifically

relevant to resolution of this matter. See Paterek v. HHS, 527 Fed. Appx. 875, 884 (Fed. Cir.

2013). This includes medical literature submitted by both sides.

1

I

THE APPLICABLE STATUTORY SCHEME

Under the National Vaccine Injury Compensation Program, 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 of factual demonstrations, including showing that an

individual received a vaccination covered by the statute; received it in the 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 under the Program – the petitioner must

also establish a causal link between the vaccination and the injury. In some cases, the petitioner

may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may

be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine

Injury Table,” corresponding to the vaccination in question, within an applicable time period

following the vaccination also specified in the Table. If so, the Table Injury is presumed to have

been caused by the vaccination, and the petitioner is automatically entitled to compensation,

unless it is affirmatively shown that the injury was caused by some factor other than the

vaccination. §300aa-13(a)(1)(A); §300aa-11(c)(1)(C)(i); §300aa-14(a); §300aa-13(a)(1)(B).

In other cases, however, the vaccine recipient may have suffered an injury not of the type

covered in the Vaccine Injury Table. In such instances, an alternative means exists to

demonstrate entitlement to 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. §300aa-

13(a)(1)(B); §300aa-11(c)(1)(C)(ii). (“Causation-in-fact” is also known as “actual causation.”)

In such a situation, the presumptions available under the Vaccine Injury Table are inoperative.

The burden is on the petitioner to introduce evidence demonstrating that the vaccination initially

caused, or significantly aggravated, the injury in question. Althen 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 of the evidence” standard, the same standard

ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines,

940 F.2d at 1525. Under that standard, the petitioner must show that it is “more probable than

not” that the vaccination initially caused or aggravated the injury. Althen, 418 F.3d at 1279. The

petitioner need not show that the vaccination was the sole cause or even the predominant cause

of the injury or aggravation, but must demonstrate that the vaccination was at least a “substantial

factor” in causing or aggravating the condition, and was a “but for” cause. Shyface v. HHS, 165

F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical sequence

of cause and effect showing that the 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 of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant v. HHS,

956 F.2d 1144, 1148 (Fed. Cir. 1992).

2

The Althen court also provided additional discussion of the “causation-in-fact” standard,

as follows:

Concisely stated, Althen’s burden is to show by preponderant evidence that the

vaccination brought about her injury by providing: (1) a medical theory causally

connecting the vaccination and the injury; (2) a logical sequence of cause and

effect showing that the vaccination was the reason for the injury; and (3) a

showing of proximate temporal relationship between vaccination and injury. If

Althen satisfies this burden, she is “entitled to recover unless the [government]

shows, also by a preponderance of the evidence, that the injury was in fact caused

by factors unrelated to the vaccine.”

Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not

necessarily supply evidence from medical literature supporting petitioner’s causation contention,

so long as the petitioner supplies the medical opinion of an expert. (Id. at 1279-80.) The court

also indicated that, in finding causation, a Program fact-finder may rely 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 of injured claimants.” (Id. at 1280.)

Since Althen, the Federal Circuit has addressed the causation-in-fact standard in several

additional rulings, which have affirmed the applicability of the Althen 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 cautioned Program fact-finders against narrowly construing the

second element of the Althen test, confirming that circumstantial evidence and medical opinion,

sometimes in the form of notations of treating physicians in the vaccinee’s medical records, may

in a particular case be sufficient to satisfy that second element of the Althen test. Both Pafford v.

HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006), and Walther v. HHS, 485 F.3d 1146, 1150 (Fed. Cir.

2007), discussed the issue of which party bears the burden of ruling out potential non-vaccine

causes. DeBazan v. HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue of what evidence

the special master may consider in deciding the initial question of whether the petitioner has met

her causation burden. The issue of the temporal relationship between vaccination and the onset

of an alleged injury was further discussed in Locane v. HHS, 685 F.3d 1375 (Fed. Cir. 2012), and

W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013). Moberly v. HHS, 592 F.3d 1315 (Fed. Cir. 2010),

concluded that the “preponderance of the evidence” standard that applies to Vaccine Act cases is

the same as the standard used in traditional tort cases, so that conclusive proof involving medical

literature or epidemiology is not needed, but demonstration of causation must be more than

“plausible” or “possible.” Both Andreu v. 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 of a causation inquiry. Broekelschen v. HHS, 618

F.3d 1339 (Fed. Cir. 2010), found that it was appropriate for a special master to determine the

reliability of a diagnosis before analyzing the likelihood of vaccine causation. Lombardi v. HHS,

656 F.3d 1343 (Fed. Cir. 2011), and Hibbard v. HHS, 698 F.3d 1355 (Fed. Cir. 2012), both again

explored the importance of assessing the accuracy of the diagnosis that supports a claimant’s

theory of causation. Doe 11 v. HHS, 601 F.3d 1349 (Fed. Cir. 2010) and Deribeaux v. HHS, 717

F.3d 1363 (Fed. Cir. 2013), both discuss the burden of proof necessary to establish that a “factor

unrelated” to a vaccine may have caused the alleged injury.

3

Another important aspect of the causation-in-fact case law under the Program concerns

the factors that a special master should consider in evaluating the reliability of expert testimony

and other scientific evidence relating to causation issues. In Daubert v. Merrell Dow

Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court listed certain factors that federal

trial courts should utilize in evaluating proposed expert testimony concerning scientific issues.

In Terran v. HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Federal Circuit ruled that it is

appropriate for special masters to utilize Daubert’s factors as a framework for evaluating the

reliability of causation-in-fact theories presented in Program cases.

II

BACKGROUND: THE OMNIBUS AUTISM PROCEEDING (“OAP”)

This case is one of more 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 within the Office of Special Masters (“OSM”). A

detailed history of the controversy regarding vaccines and autism, along with a history of the

development of the OAP, was set forth in the six entitlement decisions issued as “test cases” for

two theories of causation 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 Act petitioners who raised autism-related claims.

About 180 attorneys participated in the PSC. Their responsibility was to develop any available

evidence indicating that vaccines could contribute to causing autism, and eventually present that

evidence in a series of “test cases,” exploring the issue of whether vaccines could cause autism,

and, if so, in what circumstances. Ultimately, the PSC selected groups of attorneys to present

evidence in two different sets of “test cases” during many weeks of trial in 2007 and 2008. In

the six test cases, the PSC presented two separate theories concerning the causation of ASDs.

3

“Autism Spectrum Disorder” is a general classification which as of 2010 included five

different specific disorders: Autistic Disorder, Childhood Disintegrative Disorder, Asperger’s

Syndrome, Rett Syndrome, and Pervasive Developmental Disorder Not 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 of the types of disorders falling

within the autism spectrum. (Id.) I recognize 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 of ASD set forth in the first sentence of this footnote. However, the

DSM-V retains the same general description of ASDs. An ASD is a serious form of

neurodevelopmental disorder defined by a collection of symptoms and behaviors, including

significant impairment of social interaction and language skills, and the presence of repetitive,

stereotyped interests. E.g., Snyder v. HHS, No. 01-162V, 2009 WL 332044, at *31 (Fed. Cl.

Spec. Mstr. Feb. 12, 2009).

4

The first theory alleged that the measles portion of the measles, mumps, rubella (“MMR”)

vaccine could cause ASDs. That theory was presented in three separate Program test cases

during several weeks of trial 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 of ASD. That theory was presented in three additional test cases

during several weeks of trial in 2008.

Decisions in each of the three test cases pertaining to the PSC’s first theory rejected the

petitioners’ causation theories. Cedillo v. HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec.

Mstr. Feb. 12, 2009) aff’d, 89 Fed. Cl. 158 (2009), aff’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), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. HHS, No. 01-162V,

2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009).4 Decisions

in each of the three “test cases” pertaining to the PSC’s second theory also rejected the

petitioners’ causation theories, and the petitioners in each of those three cases chose not to

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

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

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

The “test case” decisions were comprehensive, analyzing in detail all of the evidence

presented on both sides. The three test case decisions concerning the PSC’s first theory

(concerning the MMR vaccine) totaled more than 600 pages of detailed analysis, and were

solidly affirmed in many more pages of analysis in three different rulings by three different

judges of the United States Court of Federal Claims, and in two rulings by two separate panels of

the United States Court of Appeals for the Federal Circuit. The three special master decisions

concerning the PSC’s second theory (concerning vaccinations containing the preservative

“thimerosal”) were similarly comprehensive.

All told, the 11 lengthy written rulings by the special masters, the judges of the U.S.

Court of Federal Claims, and the panels of the U.S. Court of Appeals for the Federal Circuit

unanimously rejected the petitioners’ claims, finding no persuasive evidence that either the

MMR vaccine or thimerosal-containing vaccines could contribute 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 how to

proceed with their own claims. The vast majority of those autism petitioners elected either to

withdraw their claims or, more commonly, to request that the special master file a decision denying

their claim on the written record, resulting in a decision rejecting the petitioner’s claim for lack of

support. However, a small minority of the autism petitioners have elected to continue to pursue

their cases, seeking other causation theories and/or other expert witnesses. A few such cases have

gone to trial before a special master, and in the cases of this type decided thus far, all have resulted

in rejection of petitioners’ claims that vaccines played a role in causing their child’s autism. See,

e.g., Henderson v. HHS, No. 09-616V, 2012 WL 5194060 (Fed. Cl. Spec. Mstr. Vowell Sept. 28,

4

The petitioners in Snyder did not appeal the decision of the U.S. Court of Federal Claims.

5

2012) (autism not caused by pneumococcal vaccination); Blake v. HHS, No. 03-31V, 2014 WL

2769979 (Fed. Cl. Spec. Mstr. Vowell May 21, 2014) (autism not caused by MMR vaccination);

Murphy v. HHS, No. 05-1063V, 2016 WL 3034047 (Fed. Cl. Spec. Mstr. Corcoran Apr. 25, 2016)

(autism not caused by DTaP or MMR vaccines), aff’d, 2016 WL 4926207 (Fed. Cl. Aug. 15, 2016);

Franklin v. HHS, No. 99-855V, 2013 WL 3755954 (Fed. Cl. Spec. Mstr. Hastings May 16, 2013)

(MMR and 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 MMR or Varivax

vaccines); Long v. HHS, No. 08-792V, 2015 WL 1011740 (Fed. Cl. Spec. Mstr. Hastings Feb. 19,

2015) (autism not caused by influenza vaccine); Brook v. HHS, No. 04-405V, 2015 WL 3799646

(Fed. Cl. Spec. Mstr. Hastings May 14, 2015) (autism not caused by MMR or Varivax vaccines);

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

not caused by hepatitis B vaccine), aff’d, 132 Fed. Cl. 194 (2017); Lehner v. HHS, No. 08-554V,

2015 WL 5443461 (Fed. Cl. Spec. Mstr. Vowell July 22, 2015) (autism not caused by influenza

vaccine); Miller v. HHS, No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. Vowell August

18, 2015) (ASD not caused by combination of vaccines); Allen v HHS, No. 02-1237V, 2015 WL

6160215 (Fed. Cl. Spec. Mstr. Vowell Sept. 26, 2015) (autism not caused by MMR vaccination);

R.K. v. HHS, No. 03-632V, 2015 WL 10936124 (Fed. Cl. Spec. Mstr. Vowell Sept. 28, 2015)

(autism not caused by influenza vaccine), aff’d, 125 Fed. Cl. 57 (2016), aff’d, 2016 WL 7174139

(Fed. Cir. Dec. 9, 2016); Hardy v. HHS, No. 08-108V, 2015 WL 7732603 (Fed. Cl. Spec. Mstr.

Hastings Nov. 3, 2015) (autism not caused by several vaccines); Sturdivant v. HHS, No. 07-788V,

2016 WL 552529 (Fed. Cl. Spec. Mstr. Hastings Jan. 21, 2016) (autism not caused by Hib and

Prevnar vaccines); R.V. v. HHS, No. 08-504V, 2016 WL 3882519 (Fed. Cl. Spec. Mstr. Corcoran

Feb. 19, 2016) (autism not caused by influenza vaccine), aff’d, 2016 WL 3647786 (Fed. Cl. June

2, 2016); Cunningham v. HHS, No. 13-483V, 2016 WL 4529530 (Fed. Cl. Spec. Mstr. Hastings

Aug. 1, 2016) (autism not caused by MMR vaccine), aff’d, 2017 WL 1174448 (Fed. Cl. Jan. 25,

2017); T.M. v. HHS, No. 08-284V (Fed. Cl. Spec. Mstr. Corcoran Aug. 9, 2016) (not yet published)

(autism not caused by DTaP vaccine), aff’d, 2017 WL 3184726 (Fed. Cl. June 30, 2017) ; Anderson

v. HHS, 02-1314V, 2016 WL 8256278 (Fed. Cl. Spec. Mstr. Corcoran Nov. 1, 2016) (autism not

caused by MMR vaccination), aff’d, 2017 WL 1787975 (Fed. Cl. May 5, 2017).

In addition, some autism causation claims have been rejected without trial, at times over

the petitioner’s objection, in light of the failure of the petitioner to file plausible proof of

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 caused by MMR vaccination); Fester v. HHS,

No. 10-243V, 2016 WL 1745436 (Fed. Cl. Spec. Mstr. Dorsey April 7, 2016) (autism not caused

by measles, mumps, rubella, and varicella (MMRV) vaccine); Fresco v. HHS, No. 06-469V,

2013 WL 364723 (Fed. Cl. Spec. Mstr. Vowell Jan. 7, 2013) (autism not caused by multiple

vaccines); Fesanco v. HHS, No. 02-1770, 2010 WL 4955721 (Fed. Cl. Spec. Mstr. Hastings

Nov. 9, 2010) (autism not caused by multiple vaccines); Miller v. HHS, No. 06-753V, 2012 WL

12507077 (Fed. Cl. Spec. Mstr. Hastings Sept. 25, 2012) (autism not caused by DTaP or MMR

vaccines); Pietrucha v. HHS, No. 00-269V, 2014 WL 4538058 (Fed. Cl. Spec. Mstr. Hastings

Aug. 22, 2014) (autism not caused by multiple vaccines); Bushnell v. HHS, No. 02-1648, 2015

WL 4099824 (Fed. Cl. Spec. Mstr. Hastings June 12, 2015) (autism not caused by multiple

vaccines); Bokmuller v. HHS, No. 08-573, 2015 WL 4467162 (Fed. Cl. Spec. Mstr. Hastings

June 26, 2015) (autism not caused by multiple vaccines); Canuto v. HHS, No. 04-1128, 2015 WL

9854939 (Fed. Cl. Spec. Mstr. Hastings Dec. 18, 2015) (autism not caused by DTP and DTaP

6

vaccines); Valle v. HHS, No. 02-220V, 2016 WL 2604782 (Fed. Cl. Spec. Mstr. Hastings April

13, 2016) (autism not caused by DTaP vaccine); Hooker v. HHS, 02-472V, 2016 WL 3456435

(Fed. Cl. Spec. Mstr. Hastings May 19, 2016) (autism not caused by multiple vaccines). Judges

of this court have affirmed the practice of dismissal without trial in such cases. E.g., Fesanco v.

HHS, 99 Fed. Cl. 28 (2011) (Judge Braden affirming); Canuto v. HHS, No. 04-1128V, 2016 WL

2586510 (Fed. Cl. Apr. 18, 2016) (Judge Yock affirming), aff’d, 2016 WL 5746370 (Fed. Cir.

Oct. 4, 2016).

In none of the rulings since the test cases has a special master or judge found any merit in

an allegation that any vaccine can contribute to causing autism.5

5

I am well aware, of course, that during the years since the “test cases” were decided, in

two cases involving vaccinees suffering from ASDs, Vaccine Act compensation was granted.

But in neither of those cases did the Respondent concede, nor did a special master find, that there

was any “causation-in-fact” connection between a vaccination and the vaccinee’s ASD. Instead,

in both cases it was conceded or found that the vaccinee displayed the symptoms of a Table

Injury within the Table time frame after vaccination. (See Section I above).

In Poling v. HHS, the presiding special master clarified that the family was compensated

because the Respondent conceded that the Poling child had suffered a Table Injury--not because

the Respondent or the special master had concluded that any vaccination had contributed to

causing or aggravating the child’s ASD. See Poling v. HHS, No. 02-1466V, 2011 WL 678559,

at *1 (Fed. Cir Spec. Mstr. Jan. 28, 2011) (a fees decision, but noting specifically that the case

was compensated as a Table Injury).

Second, in Wright v. HHS, No. 12-423, 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.” Wright v. HHS, No. 12-423, 2015 WL 6665600, at *2 (Fed. Cl. Spec. Mstr. Sept. 21,

2015).

The compensation of these two cases, thus, does not afford any support to the notion that

vaccinations can contribute to the causation of autism. In setting up the Vaccine Act

compensation system, Congress forthrightly acknowledged that the Table Injury presumptions

would result in compensation for some injuries that were not, in fact, truly vaccine-caused. H.R.

Rept. No. 99-908, 18, 1986 U.S.C.C.A.N. 6344, 6359. (“The Committee recognizes that there is

public debate over the incidence of illnesses that coincidentally occur within a short time of

vaccination. The Committee further recognizes that the deeming of a vaccine-relatedness

adopted here may provide compensation to some children whose illness is not, in fact, vaccine-

related.”)

7

III

PROCEDURAL HISTORY OF THIS CASE

A. Petitioners’ filing of a pro se Petition

Petitioners filed their claim pro se on November 15, 2011. (Original Petition (“Pet.”),

ECF No. 1.) That petition alleged that due to vaccinations administered to W.R. on November

19, 2008 -- specifically, the Pediarix (combination vaccine comprised of hepatitis B (“Hep B”),

inactivated polio (“IPV”), and diphtheria-tetanus-acellular pertussis (DTaP) vaccines),

haemophilus influenzae (“Hib”), and pneumococcal conjugate (“PCV”) vaccines -- caused the

onset of W.R.’s “seborrheic dermatitis, gastroesophageal reflux disease (“GERD”), as well as

other auto-immune type illnesses.” (Pet., p. 1, parenthesis in original.) This case was originally

assigned to my docket at that time. (ECF No. 3.)

Petitioners eventually filed medical records on February 17, 2012 (Exhibits (Exs.) 1-25;

ECF No. 9), and on April 12, 2012 (Exs. 26-39; ECF No. 11). On September 14, 2012, Mr. and

Mrs. Rogero filed their separate affidavits as a single court filing, marking Mrs. Rogero’s

affidavit as “Ex. 40” (ECF No. 15, pp. 2-8), and Mr. Rogero’s affidavit as “Ex. 41” (id., pp. 9-

11). Petitioners filed a status report on December 7, 2012, indicating their belief that all medical

records and affidavits were filed in this case, and that the record was ready for Respondent’s

review. (ECF No. 17.)

B. Respondent’s “Rule 4(c) Report” and Motion To Dismiss

On February 1, 2013, Respondent filed a combined “Rule 4(c) Report” and Motion To

Dismiss, opposing compensation and moving for the court to dismiss this case. (ECF No. 19.)

Petitioners contacted my chambers on March 1, 2013, informing my staff that they were

consulting an attorney; thus, I postponed all proceedings until an attorney’s appearance was

entered in this case. (ECF No. 22.) Petitioners were able to secure attorney representation, with

attorney Clifford Shoemaker taking over their case. (ECF No. 20.) This case was then

reassigned to the docket of Special Master Nora Beth Dorsey6 on March 8, 2013. (ECF No. 25.)

Petitioners filed a response to Respondent’s “Rule 4(c) Report” and Motion To Dismiss

on May 13, 2013. (ECF No. 32.) In that response, Petitioners alleged that a series of

vaccinations7 administered to W.R. at various times caused his “multiple autoimmune illnesses.”

6

Special Master Dorsey became the Chief Special Master of this Court, effective as of

September 1, 2015.

7

Although unclear at first glance, that response seemed to allege, in effect, that a series of

vaccinations administered on the following dates -- November 19, 2008 (Pediarix, Hib, and

pneumococcal vaccines); January 19, 2009 (Pediarix, Prevnar, and Hib vaccines); April 27, 2009

(Hib, Pediarix, and Prevnar vaccines); August 1, 2009 (Hib vaccine); September 24, 2009 (Hib

and varicella vaccines); and May 4, 2010 (DTaP vaccine) -- caused or aggravated W.R.’s

purported injuries. (See ECF No. 32, pp. 2-4; 4-7; 7-9; 9-10; 10-12; and 13 (discussion regarding

8

(Id., p. 43.) Petitioners described those alleged “multiple autoimmune illnesses” into three broad

categories comprised of various non-specific injuries, including: (1) “neurological conditions”8;

(2) “[i]mmunological dysregulation”9; and (3) “neuroinflammation/microglial activation and

mitochondrial dysfunction”10 injuries. (Id.) Furthermore, on May 13 and 14, 2013, Petitioners

refiled certain medical records (Exs. 5 and 18; ECF No. 29),11 and filed additional medical

records and medical literature, representing that those materials supported claims made in their

response (Exs. 42-81; ECF Nos. 30-31, 33-35).

On May 20, 2013, Special Master Dorsey denied Respondent’s Motion to Dismiss,

allowing Petitioners an opportunity to further develop their claims in this case. (ECF No. 36, p.

3.)12

W.R.’s administered set of vaccinations starting from November 19, 2008); see also ECF No. 32,

pp. 43-44.)

8

That response listed the following “neurological conditions” allegedly suffered by W.R.:

“chronic encephalopathy, toxic encephalopathy, developmental delay, oral motor dyspraxia,

gross motor delay, hypotonia, sluggish pupillary response, sensory processing deficits, motor

planning deficits, severe articulation and expressive language disorder and seizure-like

episodes.” (ECF No. 32, p. 43.)

9

Although unclear at first glance, that response seemed to allege that W.R.’s

“immunological dysregulation” is “evidenced” by various laboratory testing results. (ECF No.

32, p. 43.) Some of those laboratory testing results listed were: “folate blocking antibodies”;

“high platelets”; “antibodies to food, immunologically mediated inflammation to the intestinal

mucosa (elevated lysosome)”; and “delayed type (Type IV) hypersensitivity reactions (delayed

food allergies IgG).” (Id.) Moreover, as further “evidence” of W.R.’s “immunological

dysregulation,” that response listed other injuries allegedly suffered by W.R., such as: “atopic

dermatitis”; “allergic gastritis”; “dermatitis”; “eczema due to immune dysregulation”; in addition

to certain other injuries such as: “suggested eosinophilia esophagitis” and “repeat elevated EOS

for over two years.” (Id.)

10

That response stated that “additional evidence” of W.R.’s “neuroinflammation/microglial

activation and mitochondrial dysfunction” included various results of laboratory testing

conducted for W.R., purportedly reflecting abnormal results such as: “elevated lactic/pyruvate”;

“low Co2”; “elevated vanilamandellate”; “elevated homovanillate and porphyrins”; “high

quinolinic acid”; and “high glutamate.” (ECF No. 32, p. 43.)

11

Petitioners represented that they refiled Exs. 5 and 18 due to a scanning error that caused

certain double-sided pages to be omitted in the originally-filed exhibits. (ECF No. 29.)

12

On May 28, 2013, Petitioners filed a motion to redact Special Master Dorsey’s ruling

denying Respondent’s motion to dismiss, requesting various information to be redacted from that

ruling. (ECF No. 38.) That motion to redact was denied by Special Master Dorsey on June 28,

2013; however, she issued an order sua sponte to: (1) redact W.R.’s name to his initials in the

9

C. Development of the case

Petitioners submitted various additional materials in support of their claim on September

27, 2013. (ECF Nos. 43-46.) Those filings included: (1) medical records (Exs. 82-85; ECF No.

43); (2) the expert report and curriculum vitae of Christopher Shaw, Ph.D. (Exs. 86-87; ECF No.

44); (3) the expert report and curriculum vitae of Stephanie Seneff, Ph.D. (Exs. 88-89; ECF No.

45); and (4) supporting medical literature (Exs. 91-98; ECF No. 46).

On October 1, 2013, Petitioners submitted the expert report and curriculum vitae of

Christopher Exley, Ph.D. (Exs. 99-100; ECF No. 49.) Petitioners filed the expert report of Helen

Ratajczak, Ph.D., on October 11, 2013 (Ex. 101, ECF No. 52),13 and filed her curriculum vitae

on May 12, 2014 (Ex. 103, ECF No. 63).

On November 21, 2013, Respondent filed a Motion for Clarification of Petitioners’

Theory (“Clarification Motion”), stating that the expert reports submitted by Petitioners to that

date “postulate a litany of different theories across a host of subject areas … to explain why

[W.R.] has developmental delays, including autism,” and that it was unclear at that time as to

what “[P]etitioners’ theory is or which experts support it.” (ECF No. 53, p. 1.) Thus, Respondent

requested for Petitioners to clarify their theory of the case, and to specify exactly how that theory

was supported by the expert reports filed to that date. (Id., p. 9.)

After several extensions of time, on May 12, 2014, Petitioners filed a response to that

Clarification Motion (ECF No. 68), and submitted numerous materials, including: (1) additional

medical records (Exs. 102, 121-26; ECF Nos. 63, 67)14; (2) the expert report and curriculum

vitae of Mary Megson, M.D. (Exs. 104-05; ECF No. 64); and (3) additional medical literature

(Exs. 106-120; ECF Nos. 65-66). Petitioners’ response to that Clarification Motion indicated

that Petitioners various experts were providing “multiple theories” of causation (ECF No. 68, p.

1), but stated that “all of the [Petitioners’ expert] reports are focusing . . . on the role of

aluminum in some of the vaccines” and that “clearly a child who is genetically susceptible is one

who has difficulty excreting aluminum, thereby resulting in the aluminum accumulating in the

ruling denying Respondent’s motion to dismiss, and (2) to continue that practice in all future

filings. (ECF No. 40, p. 3.)

13

Petitioners originally filed the expert report of Dr. Ratajczak on September 27, 2013.

(See Ex. 90; ECF No. 45.) However, on September 30, 2013, Petitioners filed a motion to strike

that expert report from the record, representing that the expert report was incomplete as filed.

(ECF No. 47.) Special Master Dorsey granted that motion on October 1, 2013. (ECF No. 48.)

Thus, I have not considered Exhibit 90 in my Decision in this case.

Petitioners filed another expert report from Dr. Ratajczak on January 6, 2015 (Ex. 216).

14

Petitioners erroneously filed Ex. 103 as a “medical record” on May 12, 2014 (ECF No.

63); however, Ex. 103 is the curriculum vitae of Helen Ratajczak, Ph.D. (See Ex. 103; ECF No.

63).

10

body and leading to the deleterious effects being described.” (ECF No. 68, p. 2, ¶ 4.) In essence,

Petitioners seemed to assert that all of W.R.’s injuries are generally caused by the effects of

aluminum within vaccines, but that there are multiple theories from their experts that explain

how the aluminum within vaccines could have caused W.R.’s specific injuries. (ECF No. 68, pp.

5-7, ¶¶ 16-20; see also id., pp. 2-4, ¶¶ 4-12.)

Petitioners submitted additional medical literature on May 26, 2014. (Exs. 127-134; ECF

No. 69.) This case was reassigned to my docket on June 9, 2014. (ECF No. 70.) Over the next

year, both parties requested, and were granted, numerous requests for extensions of time to file

additional expert reports, and to further supplement the record. (See ECF Nos. 72-75, 78-79, 81,

88, 97-98, 100-101.) During that period, Petitioners submitted the expert reports of Richard

Deth, Ph.D., and Suzanne Goh, M.D. on January 2, 2015 (Exs. 149-150; ECF No. 84), and filed

their respective curricula vitae on January 13, 2015 (Exs. 224-22515; ECF No. 96). Petitioners

also submitted additional medical records and numerous medical literature throughout that

period. (See Exs. 135-148, 151-223, 226-235; ECF Nos. 82-83, 85-87, 89-95, 99, 102-03, 107.)16

During that time, Respondent submitted the expert reports and curricula vitae of Max Wiznitzer,

M.D., and Edward Cetaruk, M.D. (Exs. A-D; ECF No. 76.) The corresponding medical

literature cited in those two expert reports was submitted on December 17, 2014. (Ex. A, Tabs 1-

9 and Ex. C, Tabs 1-9; ECF No. 80.)

On May 21, 2015, Petitioners filed a status report notifying the court that their experts

would not be submitting supplemental expert reports, and that they were ready for this case to be

scheduled for a hearing. (ECF No. 104.) Thereafter, Respondent requested, and was granted,

several extensions of time to review Petitioners’ numerous filings and to retain an additional

expert. (ECF Nos. 105-06, 109-110.)

On September 28, 2015, Petitioners filed the expert report and curriculum vitae of Judy

Mikovits, Ph.D. (Exs. 236-38), and additional medical literature (Exs. 239-240). (ECF Nos. 114-

115.) Also on that date, Respondent filed the expert report and curricula vitae of Bruce Cohen,

M.D. (Exs. E-F), and Jeffrey Johnson, Ph.D. (Exs. G-H), additionally filing the corresponding

medical literature cited in those two expert reports (Ex. E, Tabs 1-11 and Ex. G, Tabs 1-15).

(ECF No. 113.)

15

Exhibits 224 and 225 are mislabeled on the electronic docket as “MEDICAL

RECORDS.” (See ECF No. 96.)

16

I note that Petitioners mislabeled numerous filings during that time period. The

mislabeling errors are as follows: (1) Ex. 215 reflects a letter from a treating doctor, Dr.

Civitello, mislabeled as “medical literature” (Ex. 215; ECF No. 93); (2) Ex. 216 reflects the

signed expert report of Dr. Ratajczak, mislabeled as “medical literature” (Ex. 216; ECF No. 93);

(3) Exs. 224 and 225 are the curricula vitae of Drs. Deth and Goh, respectively, mislabeled as

“medical records” (Exs. 224-25; ECF No. 96); (4) Ex. 227 reflects a letter from a treating doctor,

Dr. Dalton, mislabeled as “medical literature” (Ex. 227; ECF No. 99); and (5) Ex. 234 reflects

medical literature, mislabeled as “medical records” (Ex. 234; ECF No. 103).

11

I granted Petitioners’ request for an enlargement of time to file an additional expert report

on September 29, 2015. (ECF No. 117.) After holding a telephonic status conference on October

7, 2015, I issued a scheduling and prehearing order on October 8, 2015, providing a schedule for

prehearing submissions and outlining the logistical arrangements for a four-day evidentiary

hearing. (ECF Nos. 118-19.)17 At that time, hearing dates were scheduled, for November 30 thru

December 3, 2015, and for February 23 and 24, 2016. (Id.)

Petitioners filed additional medical literature on October 16, 2015 (Ex. 241; ECF No.

120), followed by a revised expert report from Dr. Deth on October 23, 2015 (Ex. 242; ECF No.

121), and the expert report and curriculum vitae of Lawrence Palevsky, M.D. on October 26,

2015 (Exs. 243-44; ECF No. 122). Over the next month, Petitioners submitted additional

medical records (Exs. 245-249, 268; ECF Nos. 123, 130) and medical literature (Exs. 250-267;

ECF Nos. 124, 126-27), in addition to the supplemental affidavit of Heather Rogero (Ex. 276;

ECF 135).18 During that time period, Petitioners also submitted a list from each expert of the top

five medical articles deemed to be the most important to support their expert theory.19 (ECF No.

125.) Later, those corresponding medical articles were re-submitted, with highlighting of the

important sections from each of those articles. (Exs. 269-75, 277-98; ECF Nos. 133, 137-39.) 20

On November 9, 2015, both parties submitted their respective pre-hearing submissions.

(ECF Nos. 129, 131.) On November 25, 2015, an emergency telephonic status conference was

held where Petitioners moved for the hearing scheduled for November 30 through December 3,

2015, to be suspended due to a sudden illness in the family of Petitioners’ counsel. (ECF No.

140.) I granted that motion. (Id.)

17

I note that due to the vast volumes of medical literature filed in this case, I added a

footnote in my prehearing order, suggesting ways to effectively facilitate the use of the medical

literature filed in this case. (See ECF No. 119.) Specifically, I noted the following:

Any party wishing to rely upon a medical article is urged to file simultaneously a short

explanation of the proposition that the article is intended to support. The relevant portion

or portions of the article may be highlighted, boxed, circled or similarly marked. This

explanation may be encompassed in the prehearing memorandum, or may appear in a

separate document.

(ECF No. 119, p. 2, fn. 2.)

18

Mrs. Rogero’s affidavit was improperly filed as “medical records” on the docket. (ECF

No. 135.)

19

Petitioners filed that list pursuant to my Scheduling Order of September 2, 2015, urging

the parties to file such a list of the most important medical articles. (ECF No. 112.)

20

In filing Exs. 269-275, Petitioners mislabeled those exhibits as “medical records,” instead

of properly filing them as “medical literature.” (Exs. 269-275; ECF No. 133.)

12

On December 21, 2015, Respondent submitted an expert report of Andrew MacGinnitie,

M.D. (Ex. I), the corresponding medical literature from his expert report (Ex. I, Tabs 1-10), and

his curriculum vitae (Ex. J). (ECF No. 144.)

A telephonic status conference was held on January 15, 2016, to reschedule the hearing

of this case. Based on the parties’ discussion, I scheduled seven hearing dates from February 25

to March 17, 2016, where both parties’ experts in this case, in addition to Heather Rogero, would

testify. (ECF No. 146.) Petitioners filed additional medical literature on February 11, 2016 (Exs.

299-303; ECF No. 147), submitting additional medical records on February 15, 2016 (Exs. 304-

305; ECF No. 149). 21 On February 23, 2016, Petitioners submitted additional medical literature

cited within Dr. Palevsky’s report, reflecting relevant portions of those medical articles

highlighted. (Exs. 306-320; ECF Nos. 150-51.) 22

D. Evidentiary hearing and posthearing briefing

A six-day evidentiary hearing was held in Washington, D.C., from February 25 thru

March 1, 2016; and on March 14 and 15, 2016. (See minute entry of proceedings dated May 13,

2016.) Overall, expert testimony was heard from 11 experts, and one fact witness, Mrs. Rogero.

The following seven experts testified on behalf of the Petitioners: (1) Dr. Mary Megson; (2) Dr.

Christopher Shaw; (3) Dr. Judy Mikovits; (4) Dr. Richard Deth; (5) Dr. Lawrence Palevsky; (6)

Dr. Helen Ratajczak; and (7) Dr. Christopher Exley. The following four experts testified on

behalf of Respondent: (1) Dr. Andrew MacGinnitie; (2) Dr. Jeffrey Johnson; (3) Dr. Edward

Cetaruk; and (4) Dr. Max Wiznitzer. Over the course of the evidentiary hearing, both parties

introduced several trial exhibits, later filing those exhibits into the record. Petitioners introduced

21

I note that, in order to give both parties a fair opportunity to fully evaluate the evidence in

this case, I set the deadline for filing medical literature for November 23, 2015. (See Orders

dated Oct. 8, 2015 and Nov. 19, 2015; ECF Nos. 119, 136.) However, my order of October 8,

2015, did not apply to the re-filing of already submitted medical literature, allowing for already-

filed medical literature to be re-submitted with highlighting of the most relevant portions of those

articles. (ECF No. 136.)

Disregarding my order of October 8, 2015, however, Petitioners continued to file vast

volumes of new medical literature after November 23, 2015, even up to the verge of the first day

of the rescheduled evidentiary hearing. (See Exs. 299-303, 306-320; ECF Nos. 147, 150-151.)

Thus, in my order dated February 12, 2016, I once again reiterated my previous orders that no

new medical article filings would be allowed prior to the hearing. (See Order, Feb. 12, 2016;

ECF No. 148.)

22

I note that despite my order dated February 12, 2016, Petitioners filed Exs. 306-20, on

February 23, 2016, representing that those exhibits were references cited within Dr. Palevsky’s

expert report, and that they were filing those articles to rectify that oversight. (ECF Nos. 150-51.)

13

seven trial exhibits into the record (Exs. 321-27; ECF Nos. 152, 154, and 163),23 while

Respondent introduced five trial exhibits into the record (Resp. Trial Exs. 1-5; ECF No. 153).

Petitioners filed their post-hearing brief (“Pet. PHB”) on August 19, 2016 (ECF No. 174),

and Respondent filed their post-hearing brief (“Resp. PHB”) on November 21, 2016 (ECF No.

177). After several extensions of time, Petitioners filed their reply brief on March 6, 2017. (ECF

No. 183.)24 Thus, this matter is now ripe for a decision.

23

I note that two of the trial exhibits introduced by Petitioners into the record were, in fact,

new medical literature offered into the record of this case. (See Ex. 323 (“Petitioners’ Trial Ex.

C”) and Ex. 327 (“Petitioners’ Trial Ex. G”); ECF No. 154.) I once again point out that filing

those two exhibits was not in compliance with three of my Orders -- i.e., Orders of Oct. 8, 2015,

Nov. 19, 2015, and Feb. 12, 2016 -- orders that explicitly warned both parties that the deadline

for filing new medical literature was on November 23, 2015. (See ECF Nos. 119, 136, and 148;

see also fns. 24 and 25 immediately above.)

I additionally note that Ex. 324 (also known as Petitioners’ Trial Ex. D), comprised of a

slide deck presentation used during the direct testimony of Dr. Deth, and was in fact different

from the slide deck emailed to Respondent’s counsel by Petitioners’ counsel prior to the

evidentiary hearing. (See Tr. 363-364.) Although I acknowledged Respondent’s counsel’s

concerns about the lack of fundamental fairness to Respondent’s experts (effectively giving them

inadequate time to properly prepare to address Dr. Deth’s direct testimony based on those slides),

I nonetheless allowed for Ex. 324 to be offered into evidence, after admonishing Petitioners’

counsel for his actions. (See Tr. 362-366.)

24

Petitioners attached a lengthy document to their reply brief, labeling that exhibit as

“Appendix A.” (ECF No. 183-1.) Petitioners’ sur-reply brief represented that Appendix A was a

document compiled by the Petitioners, listing W.R.’s medical records chronologically, with

explanations and highlighting of medical records that the Petitioners believed were purposely

omitted from discussion in Respondent’s expert reports and in Respondent’s post-hearing brief.

(ECF No. 183, p. 6.) As explained in detail in Section XVII below, I find those allegations,

among others, made by the Petitioners and their counsel, accusing Respondent’s counsel and

Respondent’s experts of various misconduct, to be baseless.

Similarly, as also explained in Section XVII, upon my close examination of the record of

this case and in my careful study of Appendix A, I find Appendix A to be wholly unreliable,

serving to actually confound the record of this case. In this regard, I point out that one major

argument advanced by Petitioners in their sur-reply brief is that Respondent’s experts omitted

evidence of W.R.’s alleged regressions after his vaccinations, especially after his DTaP

vaccination of May 4, 2010. I point out, however, that Appendix A contains numerous

statements that appear to be interpretations of W.R.’s contemporaneous medical records by the

Petitioners themselves -- interpretations of W.R. medical records in which Petitioners seemingly

self-diagnose W.R.’s apparent regressions after his vaccinations. Further, I note that none of

W.R.’s treating medical care providers, close in time to his vaccinations, actually attributed any

of W.R.’s symptoms to his vaccinations.

14

IV

FACTS

A. Medical history appearing in the medical records

W.R. was born on September 10, 2008, in Tulsa, Oklahoma. (Ex. 38, pp. 7-9, 12.) He

was seen for newborn checkups by Carl Pfanstiel, M.D., on September 17 and 30, 2008. (Ex. 7,

pp. 8-9.) Those visits were unremarkable, and he was overall assessed as being healthy. (Id.)

1. W.R.’s first set of vaccinations, and following care

W.R. was seen by Christopher Dalton, D.O., on November 19, 2008, presenting with

“bad cradle cap,” congestion, cough, sneezing, and “green nasal drainage.” (Ex. 35, p. 4.)

Developmental testing at that time revealed that he passed a majority of his developmental

milestones, but failed the milestone of “turns head to sound.” (Id.) W.R. was administered the

Pediarix (a combination vaccination comprised of the diphtheria/tetanus/pertussis (DTaP),

hepatitis B, and inactivated polio vaccines), Hib (Haemophilus influenzae type B), and

pneumococcal vaccination. (Id., p. 5.)25

On December 3, 2008, W.R. was seen by Dr. Dalton for eye drainage and rash. (Ex. 35,

pp. 6-7.) At that time, his parents reported that W.R. had a white discharge and redness around

his arms for one week, and that his cradle cap was “significantly better.” (Id., p. 6.) Upon

examination, Dr. Dalton assessed that W.R. had seborrhea (discharge) around his eyelids,

infantile eczema on his trunk and extremities, but that his cradle cap from his prior visit was

“significantly improved.” (Id., pp. 6-7.) On January 3, 2009, W.R. was seen at Saint Francis

Hospital for cough and congestion -- symptoms that his parents reported were ongoing for the

past month. (Ex. 35, p. 8; Ex. 24, p. 8.)

2. W.R.’s second set of vaccinations, and following care

W.R. had his four-month well-visit on January 19, 2009. (Ex. 35, pp. 11-12.) At that

time, his mother reported W.R. having problems of spitting up after eating and while lying down

for a diaper change. (Id., p. 11.) W.R. passed most of his four-month developmental milestones,

25

On November 25, 2008, Mrs. Rogero, W.R.’s mother, received an influenza vaccination

(“Tri Flu Fluzone”). (Ex. 83, p. 1.) As discussed in Section V(A)(7)(b) below, at least one of

Petitioners’ experts opined that W.R. was also negatively affected by Mrs. Rogero’s flu

vaccination of November 25, 2008, claiming that through breastfeeding W.R. ingested certain

particles from that flu vaccination that they believed were harmful, but I found no merit in that

allegation.

15

but failed the milestone of “rolling.” (Id.) He received Pediarix and pneumococcal vaccinations

at that time.26 (Id.)

On February 13, 2009, W.R. had a follow-up visit to evaluate his rash. (Ex. 35, pp. 52-

53.) That record reflects that eczema was present at the back of his knees and at the base of his

neck, but that his cradle cap was “much improved.” (Id., p. 52.) Mrs. Rogero reported that W.R.

was continuing to spit up and that he had ongoing problems gaining weight. (Id.) Overall, W.R.

was assessed as still being underweight, having a failure to thrive, and having feeding

difficulties. (Id., p. 53.)

On March 2, 2009, W.R. was seen by Dr. Dalton for complaints of a cough that was

reported to be ongoing for the previous five days, and for congestion. (Ex. 35, pp. 13-14.) Dr.

Dalton suspected that W.R. had a respiratory syncytial virus (RSV), and arranged for admission

at St. Francis Children’s Hospital due to W.R.’s need for suctioning. (Id., p. 14.) Upon

admission at St. Francis Children’s Hospital, W.R. was diagnosed as having RSV bronchiolitis.

(Ex. 35, pp. 15, 35-36; Ex. 24, pp. 57-64, 66.)

W.R. was seen in urgent care on March 7, 2009, presenting with a cough and a fever of

101.3 degrees Fahrenheit. (Ex. 21, p. 5.) W.R.’s physician diagnosed him with having right

otitis media (ear infection) and an unspecified fever, and prescribed an antibiotic (“omnicef”).

(Id.)

On March 11, 2009, W.R. was seen by Dr. Dalton as a follow-up for his RSV diagnosis

of March 2, 2009. (Ex. 35, p. 19.) At that time, Mrs. Rogero reported that W.R. “was not rolling

over,” and that he still had a cough. (Id.) Under the “[a]ssessment/[p]lan” section of that record,

Dr. Dalton recorded that W.R.’s “acute bronchiolitis due to RSV” was “resolved,” and assessed

W.R. to be underweight. (Id., p. 18.)27 Dr. Dalton referred W.R. to SoonerStart, an early

intervention developmental therapy program. (Id., p. 18.)

26

W.R.’s immunization records contain several ambiguities regarding W.R.’s second set of

vaccinations. Records from W.R.’s well-visit of January 19, 2009, reflect a notation of

“completed” for the Pediarix and pneumococcal vaccinations, while reflecting a notation of

“cancelled” for the “Hib” and “Varicella” vaccinations (likely meaning that W.R. was not

administered the Hib and Varicella vaccinations at that time). (See Ex. 35, p. 12.) That is, it

appears from that record that W.R. received only two vaccinations on that date -- the Pediarix (a

combination vaccine of the DTaP, hepatitis B, and inactivated polio vaccines) and the

pneumococcal vaccination.

27

I note that W.R.’s records from his visit of March 11, 2009, are filed in reverse

chronological order. Thus, Ex. 35, p. 19 is the first page of that record, followed by Ex. 35, p.

18. (See Ex. 35, pp. 18-19.)

16

W.R. was seen by SoonerStart on April 10, 2009. (Ex. 18, p. 29 of 48.)28 That record

reflects that W.R.’s parents reported “knowing he is delayed developmentally,” but that they had

“no specific concerns” at that time. (Id.) Moreover, W.R.’s developmental therapist recorded,

among other things, that W.R.’s parents were advised to:

[L]imit amount of time they hold him in standing until he is rolling and sitting

independently and trying to crawl.

(Ex. 18, p. 29 of 48.)

On April 13, 2009, W.R. was seen by Dr. Dalton for complaints of green nasal drainage

from his nose and eyes for one week, a cough for the past four days, wheezing for the past three

days, and a high temperature that started the previous day. (Ex. 35, p. 20.) He was diagnosed

with otitis media (ear infection), and was prescribed an antibiotic. (Id., p. 21.) W.R. continued to

be assessed as being “underweight.” (Id.)

W.R. was seen at urgent care on April 25, 2009, with a chief complaint of “sporadic

rashes all over.” (Ex. 21, p. 3.) W.R. was diagnosed with “unspecified urticarial” (hives), and

prescribed an antibiotic. (Id., p. 4.)

3. W.R.’s third set of vaccinations, and following care

On April 27, 2009, W.R. was seen by Dr. Dalton to be re-evaluated for his hives and

congestion. (Ex. 35, pp. 23-24.) At that time, Mrs. Rogero reported, among other things, that

W.R. was “beginning to prop up,” and that he had “started to roll over quite a bit.” (Id., p. 23.)

Overall, W.R. was assessed as having atopic dermatitis, due to “drugs-medicines taken

internally.” (Id., p. 24.) In addition, W.R. was administered the Pediarix and pneumococcal

vaccinations at that time.29 (Id.)

a. Routine care visits and specialist evaluations

W.R. was seen for his nine-month well-visit on June 16, 2009. (Ex. 35, pp. 26-27.) At

that time, W.R. failed most of his developmental milestones. (Id., p. 26.) W.R. was assessed as

being underweight, having short stature, and as being “off on his development and delayed.” (Id.,

p. 27.) W.R. was referred to have a genetic evaluation for his developmental delay and short

stature. (Id., pp. 27-28.)

On July 20, 2009, W.R. was examined by geneticist Michael Kayser, D.O., for

developmental delays and failure to thrive. (Ex. 17, pp. 4-5.) At that time, Mrs. Rogero reported

W.R.’s recent developmental history, stating, inter alia, that “[d]evelopmentally, [W.R.] sits with

28

The pagination in this record is reflected in the bottom left-hand corner of the page. (See

Ex. 18 generally.)

29

In her affidavit, Mrs. Rogero alleged that W.R. also received a Hib vaccination at his visit

of April 27, 2009. (Ex. 276, p. 8, ¶ 37.)

17

support.” (Id., p. 4.) Overall, Dr. Kayser assessed W.R. as having developmental delays and

failure to thrive, and discussed possible genetic abnormalities that could explain W.R.’s

developmental condition, ordering laboratory testing to rule out those possibilities. (Id., p. 5.)

On July 31, 2009, W.R. saw an allergist to determine whether W.R.’s lack of growth

could be due to food allergies. (Ex. 19, p. 1.) That record documents a medical history of W.R.,

as reported by Mrs. Rogero, indicating that W.R. had a history of “severe reflux,” and that he had

experienced eczema "since 2-3 weeks old.” (Id.) The allergist recommended certain skin testing.

(Id., p. 2.)

b. Developmental therapy sessions

From May to mid-July of 2009, W.R. had several developmental therapy sessions with

SoonerStart Early Intervention Program. (Ex. 18, pp. 1-6 and pp. 18-28 of 48.)30 On his

evaluation of May 5, 2009, W.R. had a “sluggish pupillary response” on vision testing (Ex. 18, p.

1 of 48), and Mrs. Rogero reported that her biggest concerns regarding W.R.’s development were

his motor skills and certain of his speech skills (id., p. 27 of 48). The therapy records reveal his

therapists’ ongoing focus on developing certain of his motor skills. (See generally Ex. 18.)

4. W.R.’s fourth vaccination visit, and following care

W.R. next received a Hib vaccination on August 1, 2009. (Ex. 1, p. 3.)

a. Routine care visits and specialist evaluations

On August 20, 2009, W.R. was seen by the allergy clinic to review the results of his

allergy testing conducted on July 20, 2009. (Ex. 19, pp. 7-8.) At that visit, Mrs. Rogero, among

other things, reported that W.R.’s eczema was “under control” (id., p. 8), and he was assessed as

having an allergy to eggs and having atopic dermatitis (id., p. 7).

b. Developmental therapy sessions

W.R. had several developmental therapy sessions with SoonerStart in August of 2009.

(Ex. 18, pp. 18-20 of 48.) Collectively, those records reveal that W.R. made some progress in

speech and motor development. (Id.) Those records also contain a notation dated September 1,

2009, documenting that Mrs. Rogero cancelled further developmental services due to her belief

that W.R. was doing well. (Ex. 18, p. 45 of 48.)

5. W.R.’s fifth set of vaccinations, and following care

W.R. was seen by Dr. Dalton for his one-year well visit on September 24, 2009. (Ex. 35,

pp. 29-31.) At that time, W.R. failed a majority of his developmental milestones. Upon

examination, W.R.’s eczema was “much improved,” but was observed to have a “mild

30

For clarity, I note that several of the SoonerStart records were filed in reverse

chronological order. (See Ex. 18, pp. 21-28 reflecting SoonerStart visits from May 18 to July 14.)

18

strabismus” (commonly referred to as being “cross-eyed”). (Id., p. 30.) He was assessed as being

“underweight” and having “mechanical strabismus,” and Dr. Dalton placed an order for W.R. to

receive his hepatitis A and varicella vaccinations at that time. (Ex. 35, pp. 29-31.)

a. Vaccinations administered on September 24, 2009

W.R.’s medical records contain discrepancies regarding the precise vaccinations that

were given on September 24, 2009. For instance, W.R.’s record of his well-visit with Dr. Dalton

on September 24, 2009, reflects that the “[h]ep A” and “[v]aricella” vaccinations were “ordered”

on that date. (Ex. 35, p. 31.) In contrast, however, another medical record labelled as “PATIENT

IMMUNIZATION RECORD” from the “Warren Clinic” reflects that W.R. was in fact

administered the hepatitis A and Hib vaccinations on September 24, 2009. (Ex. 35, p. 34.)

b. Routine care visits and specialist evaluations

W.R. was seen on November 9, 2009, by an ophthalmologist, who, among other things,

diagnosed him as having neurodevelopmental delay. (Ex. 12, p. 1.) On December 17, 2009,

W.R. had a follow-up appointment with his geneticist, Dr. Kayser. (Ex. 17, p. 2.) That record

reflects that W.R.’s chromosomal testing results were normal. (Ex. 17, p. 2; see also Ex. 24, p.

49.) Dr. Kayser recorded a medical history of W.R., stating that W.R. “has been tested

developmentally and does fall between four to five months behind on most milestones.” (Ex. 17,

p. 2.) Among other things, Dr. Kayser recommended that early intervention services should be

continued at that time to “maximize [W.R.]’s development.” (Id.)

On December 18, 2009, W.R. had his fifteen-month well-visit with Dr. Dalton. (Ex. 35,

pp. 32-33.) The record of that visit reflects that W.R. was “essentially behind with fine motor

skills and language development” (id., p. 32), and a physical evaluation revealed that he had

“eczemic and allergic dermatitis” on his face and legs (id., p. 33). Accounting for the family’s

planned move to the Washington D.C. area, Dr. Dalton recommended that W.R. needed

aggressive speech and physical therapy moving forward, and that W.R. should consult with a

developmental pediatrician upon moving. (Id., p. 33.)

c. Developmental delay testing and therapy sessions

At approximately 15 months of age, W.R. had another developmental assessment on

December 4, 2009. (Ex. 8, pp. 2-3.) At that time, he failed a majority of his developmental

milestones. (Id.)

On December 23, 2009, W.R. had a final evaluation with SoonerStart prior to the

family’s upcoming move to the Washington D.C. area. (Ex. 18, p. 16.) Among other things,

W.R.’s developmental therapist recorded Mrs. Rogero’s report that W.R. had “many perceptual

motor delays” at that time. (Id.)

W.R.’s medical records reflect that upon moving to the Washington area, he received

developmental assessments and therapy sessions through several providers. (Ex. 34.) At that

time, W.R. was assessed as being behind in several key developmental areas (id., pp. 2-6), and it

19

was determined that he would benefit from early intervention services to support his motor,

speech, and language development during daily routines (id., p. 5).31 From February through

September of 2010, W.R. continued receiving developmental, occupational, and speech therapy

sessions in Arlington, Virginia. (Ex. 34, pp. 8-9, 12-14, 20, 44-69.)

6. W.R.’s sixth vaccination visit, and following care from May through Sept. of 2010

W.R. had his 20-month well-visit with Barbara Stevens, M.D., on May 4, 2010. (Ex. 5, p.

5.) W.R. was assessed as having developmental delays at that time, and was administered the

DTaP vaccination. (Id.)

a. Routine care visits

W.R. had a follow-up appointment with Dr. Stevens on May 7, 2010, with no report of

regression or any negative symptoms. (Ex. 5, p. 6.) On June 28 and 30, 2010, W.R. was seen by

Dr. Stevens for an evaluation for rhinorrhea and constipation. (Id., pp. 3-4.) Among other things,

those records from Dr. Stevens reflect a description of W.R. as a 21-month-old boy with failure-

to-thrive and autism. (Id.)

W.R. switched pediatricians in late July of 2010, starting care with pediatricians from

Capital Area Pediatrics. (See Ex. 33 generally.) Specifically, W.R. had a consultation with a

pediatrician from that practice group on July 20, 2010, with a complaint of “autism.” (Id., p. 3.)32

That record reflects a medical history of W.R. given by Mrs. Rogero, reporting, among other

things, that W.R. had eczema issues since he was one-month of age, but that they had improved

since Mrs. Rogero eliminated eggs from W.R.’s diet. (Id.) Additionally, she reported that W.R.

had food allergies as revealed through “patch testing,” was “developmentally behind in all

areas,” was late to walk (reporting that he started to walk in May 2010), and that he had “no

speech.” (Id.)33 W.R.’s physician documented a plan to follow up with certain of W.R.’s

medical care providers, recommending that Mrs. Rogero start W.R. on physical therapy (“PT”),

occupational therapy (“OT”), and speech therapy (“ST”). (Id., p. 2.)

31

Specifically, W.R. was in the 9-12 months developmental age range for his gross motor

and fine motor skills (Ex. 34, p. 3); in the 12-16 months developmental age range for his

adaptive skills (id.); in the 5-6 months developmental age range for his expressive language

skills (id., p. 4); at the 6-months age level for his receptive language skills (id.); at the 12-months

age level for cognitive skills (id.); and his social and emotional skills were estimated to be

between 12-18 months of age (id.).

32

For clarity, I note that Ex. 33, p. 3 reflects the first page of W.R.’s evaluation of July 20,

2010, and Ex. 33, p. 2 is the second page of that evaluation. (Ex. 33, p. 3.)

33

That record also reflects Mrs. Rogero reporting, among other things, that she was

concerned that W.R. had “mercury poisoning,” and that she had “done much reading on [the]

internet” about autism, speculating about several possibilities as to the causes of W.R.’s then-

present condition. (Ex. 33, p. 3.)

20

W.R.’s medical records from Capital Area Pediatrics reflect a notation made on July 21,

2010, by one of W.R.’s pediatricians from that practice, reporting entries of that pediatrician’s

follow-up calls with W.R.’s various treatment providers. (Ex. 33, p. 2.) That record reflects that

W.R.’s pediatrician from Capital Area Pediatrics spoke with another one of W.R.’s treatment

providers, Polly Panitz, M.D., and documented Dr. Panitz’s assessment of W.R. at that time.

That record reflects the following:

She [Dr. Panitz] does not feel that food allergies or the mercury? are the cause of autism

[and] spoke [with] mom about this. She will call her again [and] reiterate that testing for

mercury will not be helpful [and change] in diet will not cure autism but may help [W.R.]

be more comfortable.

(Ex. 33, p. 2.) Moreover, that pediatrician from Capital Area Pediatrics also spoke with another

one of W.R.’s treatment care providers, Oral Alpan, M.D., recording the following notes from

that conversation:

I spoke [with] Dr. Alpan [and] he does not feel this is IgE mediated allergy. If this is an

eosinophilic enteritis some food elimination may be helpful for comfort but not curative

of the other developmental issues. He did patch testing which correlates [with]

eosinophilic enteritis [and is] not IgE mediated.

(Ex. 33, p. 2.)

b. Emergency department visits

W.R. had two emergency department visits in July and September of 2010. (Ex. 31, pp.

13-29.) On July 22, 2010, W.R. was admitted to the emergency department for complaints of

erythematous plaques around his mouth, swelling of the lip and tongue, and wheezing. (Ex. 31,

pp. 21-29.) At that time, he was assessed as having an allergic reaction. (Id.) W.R. was seen

again by the emergency department on September 18, 2010, for complaints of cough and

congestion, and was assessed with having an acute upper respiratory infection, not otherwise

specified (“Acute URI NOS”). (Id., p. 13.)

c. Specialist evaluations

W.R. was evaluated by several specialists from June to September 2010. I discuss those

visits below.

i. Developmental pediatrician

On June 8 and 15, 2010, W.R. was evaluated by a developmental pediatrician, Polly

Panitz, M.D. (Ex. 6, pp. 3-6.) During those visits, Dr. Panitz took W.R.’s medical history, as

reported by his parents, stating that W.R. “is able to babble, but does not use language in any

meaningful way,” “makes eye contact, but doesn’t always respond to being called or verbal

requests,” and that he “does not point or use other gestures.” (Id., p. 3) At that time, W.R. was

administered the “STAT” test (standardized test of autism for children two years of age),

revealing that W.R. was “well above the threshold for ‘at risk’ for autism.” (Id., p. 5.) On

21

language and cognitive testing, W.R. was assessed as having “severely delayed” language skills,

but was assessed as having normal cognitive skills. (Id.) Overall, Dr. Panitz assessed W.R. as

having “receptive and expressive language skills” that are “significantly delayed,” and as having

significant delays within his “non-verbal communicative intents.” (Id.) Dr. Panitz overall

assessed W.R. as follows:

[W.R.] engages in repetative (sic) and restricted behaviors and meets the DSM

[Diagnostic and Statistical Manual] criteria for Autism. Due to his young age, we will

defer the assignment of this diagnostic label until after his 2nd birthday, even though the

literature indicates that the presence of these significant findings is likely to be consistent.

(Ex. 6, p. 5.) Additionally, Dr. Panitz recorded that she was concerned about W.R.’s failure to

thrive, and that his weight was “most significantly impaired and inadequate for his height,”

recommending that W.R. be evaluated by several specialists. (Id., pp. 5-6.)

ii. Consultations with allergists

From July thru September of 2010, W.R. was seen on several occasions by an allergist,

Dr. Oral Alpan, and underwent numerous testing for potential allergies. (See Ex. 25, pp. 10-17;

Ex. 44, pp. 3-6, 7-8.) Collectively, those records reveal descriptions of W.R. during that time, as

reported by his parents, reflecting that he had ongoing weight problems, frequent diarrhea,

eczema still present, and a rash. (Ex. 25, p. 11; see also Ex. 44, p. 6.) Additionally, W.R.’s

evaluations by Dr. Alpan during that time period reflect that W.R. underwent “patch testing”

revealing “multiple food allergies” (Ex. 25, pp. 10, 12; Ex. 44, pp. 4-5), and was assessed with

the following: “dermatitis/atopic/eczema,” “allergic gastritis,” and “FTT” (failure to thrive) (Ex.

44, p. 5).

iii. Neurological consultations

On August 18, 2010, W.R. was evaluated by a neurologist, Stella Legarda, M.D. (Ex. 28,

pp. 13-15.) That record reflects that Mrs. Rogero requested that evaluation with Dr. Legarda,

and Dr. Legarda’s records from that consultation reflect the following:

Mom describes [W.R.] to occasionally seem to have unresponsive episodes and would

like him to be evaluated for possible seizures, something she has read may be present in

autism.

(Ex. 28, p. 13.) Overall, Dr. Legarda assessed W.R. as having an “autistic disorder current or

active state,” and with having “other convulsions.” (Id., p. 14.) In that medical record, Dr.

Legarda further elaborated upon her assessment of “other convulsions,” noting the following:

Routine EEG [electroencephalogram] is ordered. These episodes do not seem significant,

nevertheless it is helpful to obtain a baseline study evaluation in children with autism.

22

(Ex. 28, p. 14.) A 23-hour EEG study conducted on October 25, 2010, reflects that his results

were “within normal limits” and that “no epileptiform [seizure] activity” was seen on that test.

(Ex. 9, p. 144.)

On September 29, 2010, W.R. was seen by another neurologist, Lucy Civitello, M.D.,

with his chief complaint listed as “test; rule out other things.” (Ex. 9, p. 154.) That record

reflects an admitting diagnosis of “[e]ncephalopathy NOS [not otherwise specified].” (Id., p.

153). Under the patient history section of that record (“HPI”), Dr. Civitello recorded W.R.’s

medical history as reported by Mrs. Rogero. (See id., p. 154; see also id., pp. 155, 157.) In this

regard, Dr. Civitello recorded statements made by Mrs. Rogero, reporting, among other things,

that W.R. had a diagnosis of autism, that he was possibly vaccine injured due to aluminum-based

vaccines given to him at two, four, and six months of age, and that he had “severe eczema.” (Id.,

p. 154.)

iv. Other specialist evaluations

On July 6, 2010, W.R. had a consultation with a cardiologist who recorded a medical

history of W.R. described by his parents, reporting that W.R. had undergone “a number of

evaluations for developmental issues,” including evaluations for “autism, GI problems and

significant failure to thrive.” (Ex. 20, p. 1.) Upon examination, the cardiologist assessed that

W.R.’s then-present issues were not related to any cardiac conditions. (Id.)

W.R. was evaluated on July 28, 2010, by a gastroenterologist, Benjamin Enav, M.D., for

a complaint of food allergies. (Ex. 14, pp. 1-2.) The “past medical history” section of that record

states the following about W.R.’s developmental delay:

Presumed autism diagnosed in May 2010, the mother believes is mercury induced,

history of RSV, history of [food] allergies, and eczema.

(Ex. 14, p. 1.) Overall, Dr. Enav diagnosed W.R. as having a “failure to thrive,” and

recommended further testing and follow-up appointments with a dietician. (Id., p. 2.)

d. Developmental therapy sessions and public school evaluations

W.R. had numerous developmental therapy sessions from May through September 2010.

Those records collectively reflect his developmental therapists working with W.R. to meet

various developmental target goals. (See Ex. 34, pp. 10-12, 16-19, 25-36, 39, 41-42, 51-53, 55-

59, 61-62.) Moreover, W.R. received numerous special education services through Arlington

County Public Schools, and had frequent evaluations to assess his then-present levels of

academic and functional performance, relative to his developmental delays. (Ex. 4, pp. 41-44;

61-71; 73-86.)

During that time period, W.R. also had disability evaluations from state and federal

government health departments, assessing the extent of public services to be provided to meet his

developmental needs. (Id., pp. 2-13; 19.) Collectively, those records indicate that W.R. was

23

getting state and local services for his developmental delays that were attributed to his autism

spectrum disorder. (Ex. 22, pp. 2, 6, 13, 19.)34

7. Medical records since October of 2010.

The record of this case contain extensive records of W.R.’s medical treatment,

developmental therapies, evaluations, and other documents relating to the period from October of

2010 forward. I have reviewed those records, and taken them into account in my Decision, but I

will not describe them in detail here, because they have relatively little relevance to the causation

issues that I decide here. Those records demonstrate that, tragically, W.R. has continued to

suffer from an autism spectrum disorder, developmental delays, and other medical conditions.

B. Additional factual allegations made by Petitioners

1. Affidavits of Heather Rogero

W.R.’s mother, Heather Rogero, signed affidavits on August 14, 2012 (Ex. 40), and

November 5, 2015 (Ex. 276). In both of her affidavits, Mrs. Rogero made numerous statements

that veered into medical opinion testimony, offering her own opinions regarding medical and

scientific issues that are central to this case.35 I discuss those statements, in addition to her

34

Ex. 22 also reflects the approximate dates of W.R.’s various diagnoses, as reported by

Mrs. Rogero to the staff members that evaluated W.R. during his Virginia Disability Assessment

of July 8, 2010. (Ex. 22, p. 6.) In this regard, under the “Current Diagnoses” section of that

medical record, W.R.’s “failure to thrive” diagnosis reflects an approximate date of onset of

“December 2008”; his “[a]utism” diagnosis reflects an approximate date of onset of “June

2010”; his “[e]czema” diagnosis reflects an approximate date of onset of “September 2008.” (Id.)

35

See Ex. 276, p. 5, ¶ 16 (Mrs. Rogero stating that W.R.’s eczema symptoms that

temporally occurred after his first set of vaccinations were “an adverse effect” of those

vaccinations); Id., ¶ 18 (Mrs. Rogero stating that W.R.’s upper respiratory infection of January 3,

2009, was an adverse effect of his first set of vaccinations); Ex. 276, p. 8, ¶ 35 (Mrs. Rogero

stating that W.R.’s “sluggish pupillary response,” recorded in his treating doctor’s evaluation

records from April 10, 2009, was a “neurological injury indicator”); Id., p. 12 (Mrs. Rogero

presenting a chart listing what she deemed to be “mitochondrial dysfunction biomarkers” from

W.R.’s medical records); Id., p. 13, ¶ 54 (Mrs. Rogero discussing certain studies that she deemed

reflected a “biologic plausibility” of the type of neurological injuries that W.R. sustained, and

stating that W.R.’s “high glutamate” and “microglial activation” were triggered by vaccinations

as they were the “only thing not ruled out”); Id., p. 15, ¶ 63 (Mrs. Rogero stating that W.R.’s

apparent low “IGF-1” levels were a risk factor for “adverse effects from vaccinations”); Id., p.

19, ¶ 85 (Mrs. Rogero stating that certain of W.R.’s symptoms “do not fall under the criterion for

autism”); Id., pp. 19-20, ¶ 89 (Mrs. Rogero stating that certain symptoms of W.R. are

“characteristic of his encephalopathy NOS [not otherwise specified], which progressed in his

neurological records to a chronic encephalopathy to a chronic static encephalopathy”); Id., p. 20,

¶ 90 (Mrs. Rogero stating that that she spoke with a certain expert regarding how “it would be

impossible for vaccination to cause autism” and that they discussed “how encephalopathy could

24

testimony at the evidentiary hearing in Section XVII , below. In this section, however, I simply

list additional factual allegations made by Mrs. Rogero that have not been discussed

previously.36

a. W.R.’s alleged symptoms following his fourth set of vaccinations on August

1, 2009

Mrs. Rogero alleged that, soon after his Hib vaccination of August 1, 2009, W.R. would

just “flop over when sitting”. (Ex. 276, p. 9, ¶ 44.)

b. W.R.’s alleged symptoms following his sixth set of vaccinations37

i. W.R.’s alleged condition following his sixth vaccination set

Mrs. Rogero alleged that there were many differences between W.R.’s behavior prior to

his May 2010 DTaP vaccination versus after that vaccination. (E.g., Ex. 276, p. 10, ¶¶ 47, 51;

Id., p. 19, ¶ 89.) In this regard, she alleged that “something happened after” that vaccination,

claiming that after that time, W.R. was “in and out of starring [staring] spells” and that,

especially in the summer and fall of 2010, he appeared to “be in his own world.” (Id., p. 19, ¶

89.) Moreover, she alleged that W.R.’s staring spells could not be “confirmed or denied” from

his medical records, claiming that testing conducted during that time period did not properly

document his staring spells. (Id., p. 11, ¶ 53.) In this regard, she discounted W.R.’s EEG testing

results conducted in October of 2010, claiming that, prior to the start of that EEG test, W.R. had

a “spacy presentation” that was not recorded due to his EEG testing machine not being “turned

on” at that time. (Id., p. 11, ¶ 53.)

be caused by vaccination”); Id., ¶ 91 (Mrs. Rogero stating possible theories of causation for

W.R.’s injuries); Id., ¶ 92 (Mrs. Rogero stating her views on the purported high dosage of

aluminum administered to W.R. from his vaccines).

36

I note that in both of her affidavits, Mrs. Rogero stated that the record of this case was

missing records of one specific appointment that W.R. had with pediatrician Dr. Dalton,

occurring between W.R.’s second and third set of vaccinations, for a re-evaluation of a rash. (Ex.

40, p. 4 of 11, ¶ 17; Ex. 276, p. 6, ¶ 24.) That record was subsequently submitted into the record

of this case as Ex. 35, pp. 52-53.

37

In comparing Mrs. Rogero’s affidavits with W.R.’s vaccination records in this case, I

note that there is a discrepancy regarding the exact type of vaccination given to W.R. on May 4,

2010. (Compare Ex. 5, p. 2 and Ex. 1, p. 1, with Ex. 40, p. 7 of 11, ¶ 42 and Ex. 276, p. 11, ¶ 53.)

In this regard, both of her affidavits state that W.R. received the Pediarix vaccination on that

date, while W.R.’s vaccination records reflect that he was only administered the DTaP

vaccination. (Id.) At the evidentiary hearing, Mrs. Rogero stated that W.R. received the Pediarix

vaccine on May 4, 2010, but referred to that vaccination as the “DTaP” vaccine, referencing one

of W.R.’s vaccination records, Ex. 5, as support for her testimony. (Tr. 530-31.) I note, however,

that Ex. 5 reflects that W.R. was in fact administered the DTaP vaccination -- and not the

Pediarix vaccination -- on May 4, 2010. (See Ex. 5.)

25

Additionally, Mrs. Rogero’s affidavits listed selective language from certain of W.R.’s

medical records in order to describe W.R.’s condition before and after his DTaP vaccination of

May 4, 2010; she alleged, in essence, that W.R. was able to perform many tasks prior to his May

2010 vaccination that he subsequently lost after that vaccination.38 (Ex. 276, p. 10, ¶¶ 47, 51.)

Mrs. Rogero specifically recounted an alleged incident on May 29, 2010, while she observed

W.R. playing, stating that W.R. would not turn his head to sound, or engage with her upon his

name being called multiple times. (Id., p. 13, ¶ 56.) She also described another incident

occurring on May 30, 2010, at which time she observed that it was “extremely difficult” to get

W.R. to make eye contact. (Ex. 40, p. 7 of 11, ¶ 43; Ex. 276, p. 14, ¶ 57.)

Mrs. Rogero stated that it is unknown if W.R. had a seizure after his DTaP vaccination of

May 4, 2010, since W.R. slept in a separate room from his parents at that time. (Ex. 276, p. 11, ¶

53.) However, she reported that W.R. experienced a “stiff episode” around September or

October of 2011. (Id., p. 13, ¶ 54.)

2. Affidavit of Walter Rogero, II

W.R.’s father, Walter Rogero II, signed an affidavit on August 13, 2012 (Ex. 41, pp. 9-11

of 11), but did not testify at the evidentiary hearing. Mr. Rogero’s affidavit also contained

statements that veered into medical opinion testimony, offering his own opinion regarding the

medical and scientific issues that are central to this case.39 As for additional factual allegations

made in his affidavit, Mr. Rogero stated, that W.R. “lost many abilities” sometime after his

DTaP vaccination of May 4, 2010, including “saying “ma” and “da,” waving independently, and

pointing.” (Id., p. 11 of 11, ¶ 24.) Moreover, he stated that, after W.R.’s DTaP vaccination of

May 4, 2010, W.R.’s “immune responses to food” and his “eczema” increased. (Id.)

3. Mrs. Rogero’s evidentiary hearing testimony

Mrs. Rogero also testified extensively at the evidentiary hearing held in this case, on

March 1 and 15, 2016. Mrs. Rogero’s extensive testimony, among other things, included many

instances in which she read from her own prepared notes,40 or offered her own opinions

38

I note that Mrs. Rogero was referring to W.R.’s initial developmental evaluation of

January 27, 2010, as reflected on Ex. 34, pp. 2-21, to describe W.R.’s developmental condition

before his vaccinations of May 4, 2010. (Ex. 276, p. 10, ¶ 51; see also Ex. 34, pp. 2-21.) She

alleged that W.R. lost many of the abilities that he had acquired prior to his DTaP vaccination,

stating that, in the time period after May 4, 2010, W.R. specifically lost pointing, waving, turning

to his name, and his ability to vocalize different sounds. (Ex. 276, p. 10, ¶ 51.)

39

See Ex. 41, p. 11 of 11, ¶ 28 (Mr. Rogero stating that W.R. “exhibited reactions to

vaccines in keeping with known adverse effects to the individual vaccines at several points in his

development” and that “[a]ccompanying these reactions were developmental losses”).

40

E.g., Tr. 505 (Mrs. Rogero stating during her testimony that she was “just reading from

my chronological history that I made”); Tr. 509 (Mrs. Rogero acknowledging that she was

reading from prepared notes); Tr. 547 (Mrs. Rogero stating that she was essentially reading her

prepared notes that consisted of a “chronological history of” or “highlights” of W.R.’s medical

26

regarding medical and scientific issues that are central to this case.41 At other instances,

Petitioners’ counsel read excerpts from W.R.’s medical records, and solicited answers to leading

questions asked of Mrs. Rogero.42 Much of Mrs. Rogero’s testimony, however, included

statements in which she made allegations about W.R.’s symptoms or behavior. While I will

further discuss Mrs. Rogero’s testimony in Section XVII, below, in this section, I will simply list

additional factual allegations made by Mrs. Rogero that are at variance with W.R.’s

contemporaneous medical records.

records); Tr. 568 (Mrs. Rogero stating that she was reading excerpts “from her personal notes”

regarding W.R.’s condition on October 6, 2010); Tr. 581 (Mrs. Rogero stating that she was

reading excerpts comprised of “probably notes that I took from the medical records”).

41

E.g., Tr. 483-84 (Mrs. Rogero stating that W.R.’s doctor was in error when he assessed

that W.R. failed one of his two-month developmental markers); Tr. 485-86 (Mrs. Rogero stating

that W.R. had a “reaction” to her flu vaccination of November 25, 2008); Tr. 510 (Mrs. Rogero

stating that W.R. started having slight symptoms of regression in June and July of 2009); Tr. 518

(Mrs. Rogero speculating as to whether W.R. had Guillian-Barre syndrome (GBS) in his first

year of life); Tr. 544 (Mrs. Rogero interpreting certain excerpts from W.R.’s developmental

assessment of July 8, 2010, for markers of encephalopathy); Tr. 579 (Mrs. Rogero stating that

“his only regressions in the past have been associated with vaccines”); Tr. 897 (Mrs. Rogero

stating that the purpose of her rebuttal testimony was to “show in the contemporaneous medical

records where regression happened”); Tr. 900 (Mrs. Rogero providing a definition of “ill” in an

attempt to rebut Dr. Wiznitzer’s testimony regarding W.R.’s condition at two months of age); Tr.

906 (Mrs. Rogero giving definitions of medical phenomenon such as “sluggish pupillary

response” stated in W.R.’s contemporaneous medical records); Tr. 919-921, 924-27, 931-37

(Mrs. Rogero interpreting W.R.’s contemporaneous medical records for alleged instances of

regression).

42

As an example, Petitioners’ counsel read from the following of W.R.’s medical records

while asking leading questions of Mrs. Rogero: Tr. 480-81 (W.R.’s birth records); Tr. 486-87

(W.R.’s doctor visit of December 3, 2008); Tr. 487-88 (W.R.’s doctor visit of January 3, 2009);

Tr. 490-92 (W.R.’s doctor visit of Feb. 13, 2009); Tr. 492-93 (W.R.’s doctor visit of March 2,

2009); Tr. 497 (W.R.’s doctor visit of March 7, 2009); Tr. 497-98 (W.R.’s doctor visit of March

11, 2009); Tr. 499-500 (W.R.’s doctor visit of April 10, 2009); Tr. 500-01 (W.R.’s doctor visit of

April 13, 2009); Tr. 501-02 (W.R.’s doctor visit of April 25, 2009); Tr. 503-04 (W.R.’s doctor

visit of April 27, 2009); Tr. 504 (W.R.’s initial developmental evaluation of May 5, 2009); Tr.

505 (W.R.’s developmental therapy session of May 18, 2009 ); Tr. 506 (W.R.’s developmental

therapy session of June 2, 2009); Tr. 507 (W.R.’s doctor visit of June 16, 2009); Tr. 510 (W.R.’s

developmental therapy sessions in June and July 2009); Tr. 510 (W.R.’s medical visit of July 20,

2009); Tr. 515 (W.R.’s developmental therapy session of August 4, 2009); Tr. 516 (W.R.’s

developmental therapy session of August 13, 2009 ); Tr. 519 (W.R.’s one-year well visit of

September 24, 2009); Tr. 522-23 (W.R.’s 15-month well-visit of December 18, 2009); Tr. 562-

63 (W.R.’s developmental therapy session of August 25, 2010); Tr. 564 (W.R.’s doctor visit of

September 29, 2010).

27

a. Allegations regarding the reliability of W.R.’s speech therapy records starting in

March of 2010

Mrs. Rogero testified that, upon her examination of W.R.’s developmental therapy

records, she was of the belief that certain of W.R.’s speech therapy evaluations were inaccurate.

Specifically, she stated her belief that, starting in March of 2010, one of W.R.’s speech

therapists, Rebecca Whistler, had apparently pre-filled W.R.’s speech therapy session notes prior

to his actual therapy sessions. (E.g., Tr. 526-27, 552, 897-98.) In essence, Mrs. Rogero alleged

that Rebecca Whistler’s notes regarding W.R.’s speech were not an accurate,

contemporaneously-created accounting of his abilities at that time. (Id.)

b. W.R.’s alleged symptoms following his DTaP vaccination in May 2010

Mrs. Rogero testified that, twenty-seven days after W.R.’s DTaP vaccination of May 4,

2010, she “really knew something was wrong” (Tr. 531), further stating that she was unable to

get W.R. to make eye contact at that time (Tr. 531-32). At a later point in her testimony, she

testified that she “knew something was linked to the vaccines as of September 2010.” (Tr. 595.)

At another time, Mrs. Rogero testified that W.R. started having problems with his sleep after his

vaccinations administered during his first year of life. (Tr. 506.)

c. Allegations regarding Dr. Summar’s consultation notes from April 2012

Mrs. Rogero testified that Dr. Summar’s consultation notes, reflecting his examination of

W.R. in April of 2012, did not fully document Dr. Summar’s medical opinions from that visit.

(Tr. 587-89.) In this regard, she alleged that Dr. Summar had agreed to submit his revised

consultation notes from that visit, but that that request had remained pending as of the hearing.

(Tr. 587-89.)

V

SUMMARY OF EXPERT WITNESSES’ QUALIFICATIONS AND OPINIONS

In this case, each side relies upon the expert reports and hearing testimony of medical

experts. Overall, a total of 14 experts provided an expert opinion in this case, with nine of those

experts providing an opinion on behalf of the Petitioners and five of those experts providing an

opinion on behalf of the Respondent.

The following nine experts provided a medical opinion on behalf of the Petitioners: (1)

Mary Megson, M.D.; (2) Christopher Shaw, Ph.D.; (3) Judy Mikovits, Ph.D. and Francis

Ruscetti, Ph.D.43; (4) Richard Deth, Ph.D.; (5) Lawrence Palevsky, M.D.; (6) Christopher Exley,

Ph.D.; (7) Helen Ratajczak, Ph.D.; (8) Stephanie Seneff, Ph.D.; and (9) Suzanne Goh, M.D. On

behalf of the Respondent, the following five experts provided a medical opinion in this case: (1)

Andrew MacGinnitie, M.D., Ph.D.; (2) Jeffrey Johnson, Ph.D.; (3) Edward Cetaruk, M.D.; (4)

43

Drs. Mikovits and Ruscetti submitted a combined expert report in this case. (Ex. 236.)

Thus, I have grouped them together in the discussion that follows.

28

Max Wiznitzer, M.D.; and (5) Bruce Cohen, M.D. At this point, I will briefly summarize both

the qualifications and the opinions of those expert witnesses.

A. Petitioners’ experts

1. Mary Megson, M.D.

a. Qualifications

Dr. Megson earned her Bachelor of Science (B.S.) in 1974 from Hollins College, and

earned her Doctor of Medicine (M.D.) in 1978 from University of Virginia. (Ex. 105, p. 1; Tr.

11.) She completed her internship and residency at Boston Floating Hospital in 1981. (Id.)

From 1981 to 1982, Dr. Megson completed her fellowship in ambulatory pediatrics at Boston

Children’s Hospital, and from 1988 to 1990, completed her fellowship in child development at

the Medical College of Virginia. (Id.; Tr. 11-12.) She obtained board certifications from the

National Board of Medical Examiners in 1979, and from the American Board of Pediatrics in

1983. (Id.)

Dr. Megson’s notable past employment includes concurrently working within a health

maintenance organization (HMO), from 1982 to 1984, while serving as a Clinical Instructor in

Pediatrics at the Bowman Gray School of Medicine. (Ex. 105, p. 1.) From 1984 to 1988, she

worked in private practice, and from 1990 to 1999, she served as the Director of Developmental

Pediatrics at the Children’s Hospital. (Id.) From 1997 to 2001, she was a Clinical Professor of

Pediatrics at the Medical College of Virginia, rising to the rank of an Associate Clinical

professor. (Id.) She has been in private practice since 1999. (Id.)

Dr. Megson is a member of the Society of Developmental Pediatrics and a fellow of the

American Academy of Pediatrics. (Ex. 105, p. 1.)

She filed an expert report in this case on May 12, 2014. (Ex. 104.) Dr. Megson also

testified at the evidentiary hearing held in Washington, D.C. on February 25, 2016. (Tr. 11-92.)

b. Summary of Dr. Megson’s opinion

Dr. Megson opined that W.R. has certain genetic predispositions that made him “unable

to detoxify” the aluminum adjuvants contained in some of his vaccines. (Ex. 104, pp. 7-10 of 10,

Tr. 55.) She specifically pointed to the “pertussis” portion of the DTaP vaccination administered

to W.R. at 19-months of age, opining that that vaccination caused an “increased transport of

aluminum to the brain,” which eventually caused “developmental regression” and

“encephalopathy.” (Id.) She further opined that, in W.R.’s case, “each vaccination caused

chronic oxidative stress in an already weakened system,” manifesting in symptoms such as

“chronic diarrhea,” “eczema,” “allergies,” “progressive hypotonia,” “motor delays,” “dyspraxia,”

and “encephalopathy.” (Ex. 104, p. 9 of 10.)

Dr. Megson pointed to two distinct time periods in W.R.’s early years of life -- time

periods during which she deemed the “most profound and immediately obvious regressions”

occurred in W.R. (Ex. 104, p. 9 of 10.) She pointed (1) to the time period after his two-month

vaccinations, in which she opined that W.R. had an “onset of eczema” -- a symptom she deemed

was “a typical aluminum reaction,” and (2) to the time period after his DTaP vaccination at 19

29

months of age, during which, according to Dr. Megson, W.R. suffered from “developmental

regression.” (Id.)

Dr. Megson stated that W.R.’s “clinical course” supported her theory (Ex. 104, p. 7 of

10), but in this regard she primarily relied on the parental testimony, describing symptoms

allegedly suffered by W.R. immediately after each set of his administered vaccinations during

his early years of life (id., p. 1).

In addition, Dr. Megson referenced several of W.R.’s nonspecific laboratory testing

results from his medical records -- i.e., his “decreased folic acid derivatives,” low “IGF,” low

“B12 levels,” and “high glutamate” -- as apparent support for her theory (Ex. 104, p. 7), but

provided very limited explanation as to how exactly those disparate test results allegedly support

her overall causation theory in this case (id., pp. 7-10). Moreover, she provided a strong opinion

that W.R. was “exquisitely sensitive to aluminum” (id., p. 8) -- primarily relying on W.R.’s patch

testing results reflecting that W.R. had “positive skin reactions to 17/20 foods placed under

aluminum foil against the skin” (id.) -- but provided limited explanation as to why Dr. Megson

viewed those testing results to be conclusive with regards to W.R.’s apparent aluminum

sensitivities.

As to how the aluminum in the vaccines allegedly caused W.R.’s regression and

encephalopathy, Dr. Megson’s presentation was not clearly set forth, but she mentioned one

possible factor. In this regard, she pointed to the fact that W.R. has a variant in two of his genes

-- a “CCL2 heterozygous gene variant” and a “homozygous SNP” variant for the “monocyte

chemoattractant protein-1” -- opining that those variants, in combination with aluminum

adjuvants in his administered vaccinations, “overwhelmed his detoxification pathways,”

allowing for an “increased transport of aluminum into the brain,” and thus, “inducing

encephalopathy.” (Ex. 104, p. 7 of 10.)

2. Christopher Shaw, Ph.D.

a. Qualifications

Dr. Christopher Shaw earned a B.S. in Biology from the University of California Irvine

in 1971. (Ex. 87, p. 1; Tr. 94.) He earned his Master of Science (M.S.) in Physiology in 1974,

and his Ph.D. in Neurobiology in 1979, both from the Hebrew University of Jerusalem. (Id.)

From 1979 to 1985, Dr. Shaw was a postdoctoral fellow (“PDF”) at Dalhousie University,

subsequently serving as a Research Associate at that same university from 1986 to 1988. (Ex. 87,

p. 1.) From 1988 to present, Dr. Shaw has been a faculty member at the University of British

Columbia, Faculty of Medicine, in the Department of Ophthalmology and Visual Sciences, rising

to the position of Professor since 2004. (Ex. 87, p. 1; Tr. 94.)

Dr. Shaw’s curriculum vitae reflects that his research focuses on the areas of

neuroplasticity and neuropathology, with his current research focusing on “ALS-parkinsonism

dementia complex (ALS-PDC),” a neurological disorder. (Ex. 87, p. 15; Tr. 95.) His curriculum

vitae lists that he has co-authored approximately 140 peer-reviewed articles and 164 abstracts,

and has also authored three books. (Ex. 87, p. 17; Tr. 96; see also Ex. 87, pp. 17-35.) He has

served as a reviewer for several scientific journals, and has also served as an editor for several

book chapters and books. (Ex. 87, pp. 17-35.)

30

Dr. Shaw filed an expert report in this case on September 27, 2013. (Ex. 86.) He also

testified, by telephone, at the evidentiary hearing held in Washington, D.C. on February 25,

2016. (Tr. 93-146.)

b. Summary of Dr. Shaw’s opinion

Dr. Shaw mainly provided testimony on the general causation issue in this case, on the

“potential for aluminum in vaccines to damage the nervous system in some susceptible

individuals” (Tr. 96), and on the “possible role aluminum adjuvants in vaccines might play” in

causing “the range of developmental and other disorders experienced by [W.R.]” (Ex. 86, p. 1,

emphasis added).

His causation theory in this case was difficult to follow and extremely tentative, but the

crux of his opinion can be summarized as follows: (1) aluminum is a “neurotoxic” compound

(Tr. 96-98), and an elevated amount of “aluminum exposure” can cause “aluminum

neurotoxicity” (Ex. 86, p. 3; Tr. 130); (2) the amount of aluminum exposure necessary to cause

such an “aluminum neurotoxicity” can come from various sources, including “from the various

pediatric vaccines” that W.R. received in the early years of life (Ex. 86, p. 3; Tr. 130); (3) certain

individuals are especially susceptible to the “neurotoxic” effects of aluminum due to genetic

predispositions that render them unable to excrete aluminum from their bodies (Tr. 100); (4)

W.R. had one such variant -- the CCL2 gene variant -- that could render him more susceptible to

the harmful effects of aluminum (Tr. 101); and (5) W.R.’s diagnoses of “ASD and other system

disorders” could possibly arise due to the effects of “aluminum neurotoxicity” (Ex. 86, p. 3; Tr.

130). Dr. Shaw relied heavily on a perceived close temporal relationship between W.R.’s

vaccinations and the onset of his neurological disorders, reasoning that “it is clear from my

reading of the material provided about [W.R.] that the various disorders, including ASD,

followed after the vaccinations.” (Ex. 86, p. 3, emphasis in original.)

3. Judy Mikovits, Ph.D., and Frank Ruscetti, Ph.D.

On September 28, 2015, Petitioners’ filed an expert report said to be co-authored by Drs.

Judy Mikovits and Frank Ruscetti, though only Dr. Mikovits signed the report. (Ex. 236). Dr.

Mikovits also testified at the evidentiary hearing held in Washington, D.C. on February 26, 2016

(Tr. 153-211), and on March 15, 2016 (Tr. 948-986).

a. Qualifications - Judy Mikovits, Ph.D.

Dr. Mikovits earned her Bachelor of Arts (B.A.) in Biology, with a specialization in

Biochemistry, from the University of Virginia in 1980. (Ex. 237, p. 4; Tr. 154.) She earned her

Ph.D. in Biochemistry and Molecular Biology from George Washington University in 1991.44

(Tr. 154.)

From 1992 to 1994, Dr. Mikovits was a post-doctoral fellow in Molecular Virology at the

National Cancer Institute, Lab of Genomic Diversity, subsequently serving as a staff scientist at

the National Cancer Institute, Lab of Leukocyte Biology, from 1994 to 1998. (Ex. 237, pp. 3-4.)

From 1999 to 2001, she served as a Lab Director at the Laboratory of Antiviral Drug

44

The dates of her B.A. and Ph.D. are not provided in her CV.

31

Mechanisms, a division of the National Cancer Institute. (Id., p. 3; Tr. 156.) Dr. Mikovits

worked in various capacities at several biotechnology start-up companies from 2002 to 2006, and

was the Research Director of the Whittemore Peterson Institute for Neuro-Immune Disease

(WPI) from 2006 to 2011. (Ex. 237, pp. 2-3.) From 2006 to 2012, she served as a scientist and

consultant for a pharmaceutical company. (Id., pp. 1-2.) She currently is a consultant for MAR

Consulting, a consulting group she co-founded, and serves as an advisor for a private equity

investment company. (Id.) Her curriculum vitae lists 51 publications that she has co-authored.

(Id., pp. 5-9.)

b. Qualifications - Frank Ruscetti, Ph.D.45

Dr. Ruscetti received his B.S. in Biology in 1968 from Boston University, and his Ph.D.

in Microbiology from the University of Pittsburgh in 1972. (Ex. 238, p. 1.) From 1972 to 1975,

Dr. Ruscetti was a Research Instructor at the University of Pittsburgh, School of Medicine. (Id.)

From 1975 to 1978, Dr. Ruscetti worked for a private company, and since 1978, has held various

senior positions at the National Cancer Institute (NCI). (Id., pp. 1-2.) He currently serves as the

Principal Investigator for NCI’s Leukocyte Biology Section, and has been an Adjunct Professor

of Biochemistry and Molecular Biology at George Washington University -- a position he has

held since 1988. (Id.)

Dr. Ruscetti has co-authored more than 300 scientific publications, served on editorial

boards of several scientific journals and is currently on the editorial board for Stem Cells. (Ex.

238, pp. 2-32.)

As discussed above, although Drs. Ruscetti and Mikovits are said to have co-authored an

expert report (Ex. 236), Dr. Ruscetti did not testify at the evidentiary hearing.

c. Summary of Dr. Mikovits’ and Dr. Ruscetti’s expert report

Ex. 236, as previously noted, was referenced by Petitioners as the joint opinion of Drs.

Mikovits and Ruscetti, but was signed only by Dr. Mikovits.46 The report is somewhat curious,

as it in part discusses the specific case of W.R. (Ex. 236, pp 1-5, 11-19 of 19) and seems to imply

that W.R. was injured by his vaccinations, but never actually states directly that W.R. himself

has any vaccine-caused injuries (e.g., id. at p. 19 of 19). Further, the “Theory” section of the

report is a vague discussion suggesting that disruptions of a person’s immune system early in life

can result in “long-term consequences to the immune and neuronal systems” (p. 6), but does not

focus on vaccinations as a possible source of such disruptions (pp. 6-10).

45

As will be explained below, it is unclear to what extent, if any, Ex. 236 represents the

views of Dr. Ruscetti, rather than simply those of Dr. Mikovits. However, in the interest of

completeness, I will summarize the qualifications of Dr. Ruscetti.

46

In my analysis of this case, I have assumed that Dr. Ruscetti co-authored Ex. 236. Even

under this assumption, I find that the report offers scant support to Petitioners’ overall causation

case, and was heavily outweighed by contrary reports and testimony of Respondent’s experts.

32

d. Dr. Mikovits’ opinion at the hearing

Dr. Mikovits’ opinion stated during the evidentiary hearing was never clearly or

coherently explained, but as I understand it, her opinion can be summarized as follows. Dr.

Mikovits opined that, due to certain genetic susceptibilities in W.R., his vaccinations triggered a

“cytokine storm” (Tr. 174) that sent his immune system into a “state of chaos” (Tr. 199),

resulting in ongoing “inflammation” due to an overstimulation of his immune system (Tr. 204).

She opined that the vaccine-induced overstimulation of W.R.’s immune system had “profound

long term effects on [W.R.’s] innate and adaptive immune system” (Ex. 236, p. 6), pointing to

W.R.’s “innate immune system” as being particularly negatively affected -- the aspect of the

immune system that she deemed was responsible for brain development (Ex. 236, p. 19; see also

Tr. 188-89). In this regard, Dr. Mikovits opined that due to the apparent harm to W.R.’s

“innate immune system,” W.R. developed an “autoimmune response” (Tr. 165-66), which, in

turn, caused numerous neurodevelopmental issues in W.R., such as “mitochondrial dysfunction”

(Tr. 195), “encephalopathy,” “hypotonia,” “myelitis,” and “inflammation of the muscles” (Tr.

200).

Aside from those general points, the precise scope of her expert testimony seemed to shift

throughout the litigation, often veering into opinions concerning medical disciplines in which she

was wholly unqualified. My understanding of her very unclear opinion in this case, however, is

that Dr. Mikovits relied on a few critical premises for her expert opinion. One premise was that

W.R. suffered a significant immune reaction” to his vaccinations on November 19, 2008, thus

triggering an overstimulated “inflammatory” response in W.R., which was “not resolved at the

time of subsequent vaccinations” (Ex. 236, p. 11). A second premise upon which Dr. Mikovits

relied for her theory was the assertion that, each time W.R. was given vaccinations, he developed

numerous symptoms indicative of an ongoing inflammatory response and immune system

dysfunction. (E.g., Ex. 236, pp. 4, 12, 13.)

4. Richard Deth, Ph.D.

a. Qualifications

Dr. Deth received his B.S. in Pharmacy from the State University of New York at Buffalo

in 1970, and his Ph.D. in Pharmacology from the University of Miami School of Medicine in

1975. (Ex. 224, p. 1; Tr. 277.) He completed his post-doctoral training at the Catholic University

of Leuven (Belgium) in 1976. (Id.)

Dr. Deth was a registered pharmacist from 1972 to 1976. (Ex. 224, p. 1; Tr. 277.)

Starting in 1976, he held various faculty positions at Northeastern University, serving as a

Professor of Pharmacology for many years beginning in 1987. (Id.)47 He is currently a Research

Professor at Florida Atlantic University, a position he has held since 2013, and is also

concurrently a Professor of Pharmacology at Nova Southeastern University since 2014. (Id.)

47

Dr. Deth’s CV lists that from “1987-Present,” he has been a “Professor of

Pharmacology.” (Ex. 224, p. 1.) His CV is unclear, however, concerning the academic

institutions at which he served as a “Professor of Pharmacology” between 1987 and 2013. (Id.)

33

Dr. Deth is currently on the scientific advisory boards of Autism Research Institute and

Immunotec Inc., and previously served on the board of the National Autism Association. (Ex.

224, p. 2.) His curriculum vitae lists that he has co-authored 100 scientific articles, authored a

monograph, and holds four patents for methods of diagnosing schizophrenia. (Ex. 224, pp. 2-11;

Tr. 278.)

Dr. Deth’s first report was filed on January 2, 2015 (Ex. 149), and his revised expert

report was filed on October 23, 2015 (Ex. 242). He also testified at the evidentiary hearing held

in Washington, on February 29, 2016. (Tr. 276-378.)

b. Summary of Dr. Deth’s opinion

Dr. Deth’s opinion in this case was very unclear and difficult to follow, and he seemed to

contradict himself as to the precise scope of his opinion. For instance, in his expert report and

hearing testimony, Dr. Deth seemed at times to provide not only a general causation opinion (i.e,

that the types of vaccinations given to W.R. can cause the types of developmental delays from

which W.R. suffers), but also a specific causation opinion (i.e, that the vaccinations received by

W.R. did cause W.R.’s own developmental delays). (E.g., Ex. 242, p. 2; Tr. 348-60.) At other

instances, however, Dr. Deth testified that he was only addressing the general causation issue in

this case, stating that his opinion was limited to opining on the “molecular perspective of

neurodevelopment,” and not to how that theory applies to the case of W.R. (E.g., Tr. 362.)

The crux of Dr. Deth’s apparent theory can be summarized as follows: ( 1) a cellular

process called “methylation” plays a critical role in “guiding normal development” (Ex. 242, p.

2); (2) a combination of W.R.’s “genetic risk factors” (Tr. 361), and his laboratory testing

revealing low levels of a compound called “insulin-like growth factor-1” (“IGF-1”) that

“promotes methylation” (Ex. 242, p. 2), combined to place W.R. at an increased risk for

“impaired methylation” (Tr. 361); (3) W.R.’s vaccinations significantly aggravated his already

impaired “methylation” process (Ex. 242, p. 2), by promoting a phenomenon called “oxidative

stress” -- a phenomenon that also leads to “impaired methylation” (Ex. 242, p. 22); and (4)

W.R.’s significantly impaired methylation, aggravated by his vaccinations in the early years of

life, in turn, caused a “material and substantial contribution” to W.R.’s “impaired development.”

(Tr. 361). Thus, Dr. Deth opined that W.R.’s vaccinations in the early years of his life were “an

important contributing factor to the encephalopathy that in [W.R.]’s case manifested itself as

neurodevelopmental delay and autism.” (Ex. 242, p. 22.)

Although Dr. Deth stated at one point during the evidentiary hearing that his theory was

limited to the “molecular perspective of neurodevelopment” (Tr. 362), he also stated in his

expert report that W.R.’s clinical record “provides clear evidence of sporadic episodes of

decreased physical growth which correspond to time intervals following vaccinations” (Ex. 242,

p. 22). Moreover, he stated that W.R.’s underlying “oxidative stress” and “impaired

methylation” induced by his vaccinations also resulted in additional clinical features of

“mitochondrial dysfunction,” “autoimmune activation,” and an “abnormal GI function” --

deeming those clinical features to be reflective of the “additional sequelae of oxidative stress.”

(Ex. 242, p. 22.) At the evidentiary hearing, however, he walked back his statements regarding

references to W.R.’s “clinical record,” testifying that he essentially relied on a chart

retrospectively prepared by Mrs. Rogero about W.R.’s growth -- i.e., a chart not within W.R.’s

medical records. (Tr. 348-49.) Similarly, he testified that he relied on Dr. Civitello’s letter, Ex.

34

102, as support for his statements that W.R.’s “medical records” provided “evidence of vaccine-

associated developmental delay” (Tr. 361), instead of making his own assessment of W.R.’s

contemporaneous medical records.

5. Lawrence Palevsky, M.D.

a. Qualifications

Dr. Palevsky received his A.B. degree from Vassar College in 1983, and his M.D. from

the New York University School of Medicine in 1987. (Ex. 244, p. 2; Tr. 444.) From 1987 to

1990, he completed his internship and residency in pediatrics at the Mount Sinai Medical Center,

subsequently completing a fellowship in ambulatory care pediatrics in 1991 at Bellevue

Hospital-New York University School of Medicine. (Id.)

Dr. Palevsky held various positions at New York Medical College from October 1991 to

June 1995, serving as an Assistant Professor at the Department of Pediatrics and as an Assistant

Professor at the Department of Emergency Medicine. (Ex. 244, p. 2.) From July 1995 to May

2000, he served in various positions at Lenox Hill Hospital, an affiliate of the New York

University School of Medicine, notably serving as Chief of the Pediatric Acute Care Unit. (Id., p.

1; Tr. 445.) From January 1994 to June 1996, Dr. Palevsky also concurrently served as an

Adjunct Clinical Instructor at the Mount Sinai School of Medicine, Department of Pediatrics.

(Ex. 244, p. 1.) Starting in May 2000, he has held several positions as a pediatrician and medical

consultant at various “holistic health” pediatric practices. (Ex. 244; Tr. 445.)

Dr. Palevsky has made several medical appearances and given numerous lectures on the

safety and efficacy of vaccines and holistic medicine. (Ex. 244, pp. 3-5.) He was a Fellow at the

American Academy of Pediatrics and has held leadership positions within several holistic care

medical associations. (Id., p. 3.) Since 2004, he has served as a member of the Medical Advisory

Board of the Developmental Delay Resources. (Id.) Dr. Palevsky was a board-certified

pediatrician from November 1990 to December 2011, but is currently not board-certified. (Id.)

Dr. Palevsky filed an expert report on October 26, 2015. (Ex. 243.) He also testified at

the evidentiary hearing held in Washington, D.C. on March 1, 2016. (Tr. 444-478.)

b. Summary of Dr. Palevsky’s opinion

Dr. Palevsky stated that the purpose of his expert opinion in this case was to simply

“present a plausible reason for how the vaccines may have contributed to [W.R.’s] current state

of neurodevelopment.” (Tr. 447, emphasis added.) His testimony was very vague and difficult

to follow, but as I understand it, his opinion is as follows. Dr. Palevsky opined that W.R.’s brain

development was disrupted after various components from his vaccinations, including

“polysorbate 80” and “aluminum adjuvant nanoparticles” (Tr. 457), breached the “blood-brain

barrier” -- the mechanism that normally protects the brain “from most materials that circulate in

the bloodstream” (Tr. 455). (See also Ex. 243, pp. 8-10; Tr. 454-465, 476.) Moreover, he

opined that the harmful materials that entered W.R.’s brain caused an inflammation in his brain,

thus leading to W.R.’s various neurodevelopmental disorders, such as “chronic encephalopathy,”

“developmental delays,” and “regression.” (Ex. 243, pp. 4-5.)

35

As to how W.R.’s neurodevelopmental condition was caused by his vaccinations, Dr.

Palevsky’s theory was vague, but seemingly focused on the state of W.R.’s immune system at

two months of age. (Tr. 462-65.) He seemed to opine that, at two months of age, W.R. already

had a severely challenged immune system, as indicated by “an elevated level of inflammation”

shown by his symptoms of “eczema” and “increased mucous production” (Tr. 463) -- elevated

levels of inflammation that significantly increased due to W.R.’s first set of vaccinations in

November of 2008 (Tr. 462-64), thus triggering a “cycle of chronic inflammation” (Tr. 464).

Regarding this “cycle of inflammation,” Dr. Palevsky seemed to indicate that, immediately after

his first set of vaccinations, W.R. showed delays due to his then-present high levels of

inflammation, followed by a period of time when W.R. “started to improve,” but then continued

to “show significant signs of inflammation through most of his first couple years of life” due to

his continued exposure to vaccinations containing inflammation-inducing materials. (Tr. 464.)

Dr. Palevsky also indicated that materials in W.R.’s vaccinations, especially “polysorbate 80”

and “aluminum adjuvant nanoparticles,” contributed to a heightened level of inflammation in

W.R.’s body and brain (Tr. 410), but how those materials allegedly did so was never clearly

explained.

6. Christopher Exley, Ph.D.

a. Qualifications

Dr. Exley received his Ph.D. in Ecotoxicology of Aluminum, from the University of

Stirling.48 (Ex. 100, p. 1; Tr. 648.) He has written several book chapters and published over 100

articles regarding the potential harmful effects of aluminum. (Ex. 100, pp. 1-8; Tr. 651-52.) He

is currently a Professor of Bioinorganic Chemistry at Keele University in Staffordshire, United

Kingdom. (Ex. 100, p. 1; Tr. 650.)

Dr. Exley filed an expert report on October 1, 2013. (Ex. 99.) He also testified at the

evidentiary hearing held in Washington, D.C. on March 14, 2016. (Tr. 647-713.)

b. Summary of Dr. Exley’s opinion49

Dr. Exley seemed to limit his opinion in this case to the general causation issue, simply

providing mere possibilities as to the “question of how an aluminum adjuvant administered in a

vaccine might bring about an adverse event in a recipient.” (Ex. 99, p. 1 of 4, emphasis added.)

His overall theory was that aluminum adjuvants contained in vaccines are “biologically reactive”

(Tr. 654), and thus have the potential to cause harm once injected into the body (Ex. 99, pp. 1-3

of 4; Tr. 654-56). He stated three possibilities in his expert report as to how aluminum adjuvants

could be harmful once injected into the human body via vaccinations: (1) that the aluminum in

48

The dates of Dr. Exley’s B.S. and Ph.D. are not listed within his CV, and were not

provided during his evidentiary hearing testimony.

49

I note that I am well aware of the fact that throughout Dr. Exley’s expert report and

testimony, he spelled “aluminum” with an alternative British spelling of “aluminium.” (See Ex.

99, pp. 1-3.) For convenience’s sake, however, I will use the standard American spelling of

“aluminum” throughout this section and the discussion to follow, including when quoting certain

portions of Dr. Exley’s expert report and testimony.

36

adjuvants, either through a single vaccine or through multiple vaccines, accumulates in the body

until a critical threshold of aluminum is reached triggering “aluminum-related” negative effects

(Ex. 99, p. 2); (2) that the “immediate response” to the aluminum adjuvant causes the immune

system to trigger a response mirroring the strong response of a “fully blown disease,” thus

triggering a “cascade of events throughout the body” in response to the aluminum (Ex. 99, pp. 2-

3); and (3) that the inherent “potency” of the aluminum adjuvant causes the aluminum adjuvant

to “‘turn’ almost anything into an antigen,” thus causing “immune-like reactions” wherever

aluminum may be in the body (Ex. 99, p. 3).

Dr. Exley seemed to acknowledge, however, that his general causation opinion in this

case was still at an experimental level (Tr. 703-04), with his expert report simply serving as an

argument as to why researchers should “now undertake research to understand how aluminum

adjuvants actually work” (Ex. 99, p. 3). In this regard, he admitted as follows:

The scientific literature pertaining to the toxicity of aluminum in humans is not as yet

sufficiently developed to allow for direct cause and effect relationships in relation to

[W.R.]’s exposure to aluminum, through vaccinations, and his medical conditions.

(Ex. 99, p. 3.)

7. Helen Ratajczak, Ph.D.

a. Qualifications

Helen Ratajczak received her B.S. in Chemistry, M.S. in Agricultural Biochemistry and

Nutrition, and Ph.D. in Molecular Biology, all from the University of Arizona.50 (Ex. 103, p. 1;

Tr. 621-22.) Her notable employment experience include being a Research Associate at the

University of Pittsburgh in the Department of Surgery from 1980 to 1981, and an Assistant

Professor in the Department of Pathology at the Loyola University Stritch School of Medicine

from 1981 to 1983. (Ex. 103, p. 1.) She currently serves as an Adjunct Associate Professor at the

Illinois Institute of Technology’s Department of Biology -- a position she has held since 1994.

(Id.; Tr. 623.)

Dr. Ratajczak served in various immunology research roles from 1990 to 1998, rising to

be the Group Leader of Immunology at the Illinois Institute of Technology Research Institute.

(Ex. 103, p. 1.) Dr. Ratajczak served as a Senior Scientist in the Toxicology and Safety

Assessment Department at a private pharmaceutical company from 1999 until 2006. (Id.; Tr.

623.) She has been involved in autism research since 2002, with particular interests in autism

drug discovery proposals and the objective measures of autism. (Ex. 103, p. 1; Tr. 624.)

Dr. Ratajczak has co-authored more than 80 scientific publications and presentations.

(Ex. 103, pp. 2-10.) She is a member of several scientific organizations, notably the Autism

Society of America, the American Association of Immunologists, and the Society of

Immunotoxicology. (Id., pp. 1-2.)

50

The dates of Dr. Ratajczak’s academic degrees are not listed in her CV.

37

Petitioners filed Dr. Ratajczak’s first written report on October 11, 2013 (Ex. 101), and a

second report on January 6, 2015 (Ex. 216). She also testified at the evidentiary hearing held in

Washington, on March 14, 2016 (Tr. 621-646).

b. Summary of Dr. Ratajczak’s opinion

Dr. Ratajczak’s overall theory seemed to be that it is “biologically plausible” that W.R.’s

vaccinations could have weakened his “blood-brain barrier” and allowed for harmful materials

from his vaccinations to enter his brain, thus causing “inflammation” that eventually led to

neurological damage. (Ex. 216, pp. 1-4 of 5; Tr. 628-630.) As to how W.R.’s “blood-brain

barrier” might have been weakened, she opined that due to the “many antigens” contained in

vaccinations, the cumulative effect of the administration of numerous vaccinations administered

at the same time caused a “tremendous immune response” in W.R. -- a tremendous immune

response, which, in turn, caused his “blood-brain barrier” to be weakened. (Ex. 216, p. 1; see

also Tr. 628-30).

Moreover, she pointed to W.R.’s “C677T MTHFR” gene variant, opining that that variant

“could have affected the development of his immune system.” (Ex. 216, p. 1, emphasis added.)

In this regard, she opined that W.R.’s symptoms at two months of age, such as his “cough,”

“congestion,” “sneezing,” “green nasal discharge,” and “cradle cap” were reflective of W.R.’s

already weakened immune system due to his “C677T MTHFR” gene variant at that time. (Id.,

pp. 1-2). Dr. Ratajczak opined that an individual’s immune system is “particularly sensitive at

two months of age.” (Ex. 216, p. 2; Tr. 632, 633-35.) In this regard, she indicated that, soon after

W.R.’s vaccinations of November 19, 2008, “tremendous developmental delay * * * set in” on

W.R., and that such developmental delay was “quite profound” (Tr. 633) -- seemingly

contradicting certain testimony given by other of Petitioners’ experts in this case, opining that

W.R. underwent a gradual regression after his first set of vaccinations.

Beyond that general framework, however, it was unclear what exactly Dr. Ratajczak’s

opinion was in this case, as her opinion shifted throughout this litigation. For instance, although

her expert report explicitly stated that she was opining on the “many theories of causation of

autism” (Ex. 216, p. 1), and the “biological plausibility of the cause of autism for [W.R.]” (id., p.

2), at the evidentiary hearing she shifted her opinion as to the exact injury that W.R. suffered

from, now stating, without elaboration, that W.R.’s vaccinations caused an “encephalopathy”

(e.g., Tr. 628, 630-31).

Similarly, she opined that Mrs. Rogero’s flu vaccination of November 26, 2008, also

negatively harmed W.R., since he was exposed to the mercury contained in Mrs. Rogero’s flu

vaccination through breastfeeding, but failed to provide any specifics as to how that effect could

come about. (Tr. 631-634.) Instead, she stated, without explanation or elaboration, that W.R.

underwent “even more developmental delay and regression” after his mother’s flu vaccination of

November 26, 2008. (Tr. 634.)

8. Stephanie Seneff, Ph.D.

a. Qualifications

Dr. Seneff received her B.S. in Biophysics in 1968, her Masters of Science in Electrical

Engineering in 1980, and her Ph.D. in Electrical Engineering and Computer Science in 1985, all

38

from the Massachusetts Institute of Technology (MIT). (Ex. 89, p. 1.) From 1985 to present, she

has been at MIT’s Computer Science and Artificial Intelligence Laboratory, currently serving as

a Senior Research Scientist. (Id., pp. 1-2.) Dr. Seneff has published numerous articles in

technical journals, written two book chapters, and has presented at several conferences in her

field of specialty of electrical engineering and computer science. (Id., pp. 4-22.) Her curriculum

vitae also reflects, however, that she has co-authored several articles concerning the topics of

aluminum exposure and autism -- i.e., topics that are not within her field of specialty. (Ex. 89.)

Dr. Seneff filed an expert report on September 27, 2013 (Ex. 88), but did not testify at the

evidentiary hearing in Washington, D.C.

b. Summary of Dr. Seneff’s opinion

Dr. Seneff opined that W.R. “suffered from extensive damage to the brain,” “digestive

tract,” and “skeletal muscles,” mainly due to an “exposure to toxic levels of aluminum” from the

series of vaccinations that W.R. received in the early years of his life. (Ex. 88, p. 1 of 7.) She

pointed to W.R.’s gene variant in the “MTHFR gene,” attributing that variant as causing an

impairment in W.R.’s “ability to detoxify aluminum” (id., p. 2), which, according to Dr. Seneff,

allowed for aluminum “to infiltrate the brain and damage neurons” (id.). Moreover, she opined

that, due to this phenomenon of aluminum infiltrating the brain, a “low-grade encephalopathy”

(id., p. 5) was triggered in W.R., thus causing “brain damage and subsequent manifestations of

delayed neurobehavioral development” (id.).

As support for her theory, Dr. Seneff cited to several of her own articles in her expert

report, stating that “excess exposure to aluminum” could lead to a “chronic low-grade

encephalopathy that would slowly damage the brain.” (Ex. 88, p. 2.)51

Dr. Seneff’s expert report also veered into opining on medical specialties in which she

was wholly unqualified to provide an expert opinion. For instance, despite the fact that she is not

a medical doctor, Dr. Seneff provided numerous clinical assessments of W.R., diagnosing W.R.

with, among other things, “developmental regression” following his 19-month DTaP vaccination

(Ex. 88, p. 2), “mitochondrial dysfunction” (id., p. 3), and “chronic low-grade encephalopathy”

(id., p. 5) -- all diagnoses she opined to be due to aluminum exposure from vaccinations (id., pp.

2-5). In this regard, she provided broad-sweeping conclusions, without further explanation or

elaboration, asserting that W.R.’s “medical records are a “textbook example” of the

consequences of acute exposure due to multiple simultaneous vaccinations.” (Id., p. 5.)

9. Suzanne Goh, M.D.

a. Qualifications

Dr. Goh received her B.A. in History and Science from Harvard University in 1997, and

her M.D. from Harvard Medical School in 2004. (Ex. 225, p. 1.) She completed her internship in

51

Dr. Seneff’s expert report also cited her articles generally, stating that aluminum is a “key

contributor to the adverse reactions associated with vaccines,” and that aluminum could also be a

“potential contributor to the current autism epidemic.” (Ex. 88, p. 2)

39

Pediatrics at the Massachusetts General Hospital in 2005, and her residency in Pediatric

Neurology from the University of California, San Francisco in 2008. (Id.) Thereafter, she

completed her postdoctoral research fellowship in 2009, and her postdoctoral clinical fellowship

in 2011, both from Columbia University, College of Physicians & Surgeons, Division of Child

and Adolescent Psychiatry. (Id.) She is board-certified in Neurology, with a special qualification

in Child Neurology. (Id.)

Dr. Goh was an Attending Neurologist at the Columbia University Medical Center from

2009 to 2012. (Ex. 225, p. 1.) From July 2011 to December 2012, she concurrently served as an

Assistant Professor of Clinical Neurology at Columbia University College of Physicians &

Surgeons, and as a Co-Director of the Developmental Neuropsychiatry Program for Autism and

Related Disorders at that same institution. (Id.) From 2013 to present, she has been a pediatric

neurologist in private practice, concurrently working as an author and co-developer of the

Autism Spectrum Disorder (ASD) Language curriculum. (Id.) She has co-authored six books,

one book chapter, eight peer-reviewed articles, and two case reports. (Id., pp. 2-4.)

Dr. Goh filed an expert report on January 2, 2015 (Ex. 150), but did not testify at the

evidentiary hearing.

b. Summary of Dr. Goh’s opinion

Dr. Goh’s written opinion was extremely short and speculative in nature, and merely

stated her view that “a disturbance of mitochondrial function” was a “potential theory of

causation” in this case. (Ex. 150, p. 1, emphasis added.) In this regard, she seemed to opine that

W.R. potentially had an “impaired mitochondrial function” (Ex. 150, p. 1) due to certain

“underlying vulnerability” (id., p. 2), but provided very little explanation as to why she held that

belief. Similarly, her expert report was unclear as to the precise scope of her opinion, providing

vague statements as to the exact injuries that she alleged were caused by W.R.’s vaccinations.

Dr. Goh’s expert report cited some studies that purportedly provided support for her view

that the “[i]mpaired function of mitochondria” is a “factor in numerous human diseases,

including Autism Spectrum Disorders” (Ex. 150, p. 1), but failed to provide further elaboration

on those statements. Similarly, her expert report attempted to provide “several mechanisms by

which vaccines may lead to brain injury in those who have an underlying vulnerability in

mitochondrial function” (id.), listing an “inflammatory response” and “aluminum neurotoxicity”

as two possible mechanisms (id., pp. 1-2), but did not take a position on what mechanism would

be more likely in W.R.’s case.

Importantly, Dr. Goh relied on parental assertions concerning W.R.’s condition, before

and after his 19-month DTaP vaccination, to provide support for her opinion that W.R.’s case

points to “mitochondrial impairment exacerbated by vaccination.” (Ex. 150, p. 1.)

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B. Respondent’s experts

1. Andrew MacGinnitie, M.D., Ph.D.

a. Qualifications

Dr. MacGinnitie received his B.A. in psychology from Yale University in 1987, and a

Ph.D. in pathology in 1996 and a M.D. in 1998, both from the University of Chicago, Pritzker

School of Medicine. (Ex. J, p. 1; Tr. 214-15.) He completed his residency in pediatrics in 2001,

and his fellowship in allergy/immunology in 2004, both from the Children’s Hospital in Boston.

(Id.) From 2004 to 2011, Dr. MacGinnitie held concurrent clinical and faculty appointments at

the University of Pittsburgh School of Medicine, serving as an Assistant Professor of Pediatrics

and as an Attending Physician in Pediatrics and Allergy/Immunology at the University of

Pittsburgh Medical Center. (Id.) Since 2011, he has held these same concurrent positions at the

Harvard Medical School and the Children’s Hospital Boston. (Ex. J, p. 1; Tr. 215-17.)

Dr. MacGinnitie also served as a consultant and as a member of the scientific advisory

board for various pharmaceutical companies. (Ex. J, p. 2.) He is a reviewer for several medical

journals, and an editorial board member of the Annals of Allergy, Asthma and Immunology, in

addition to the Journal of Allergy and Clinical Immunology: In Practice. (Id., p. 3; Tr. 218.) He

has published numerous medical articles and book chapters in peer-reviewed journals, and has

regularly given presentations within his area of specialty throughout his career. (Ex. J, pp. 5-14.)

Dr. MacGinnitie filed an expert report on December 21, 2015. (Ex. I.) He also testified at

the evidentiary hearing held in Washington, D.C. on February 26, 2016. (Tr. 214-269.)

b. Summary of Dr. MacGinnitie’s opinion

Dr. MacGinnitie was offered as an expert in allergy and immunology, and primarily

offered a rebuttal to Dr. Mikovits’ expert opinion in this case. Overall, Dr. MacGinnitie opined

that there was “no evidence” that W.R. had an overactive immune system after any of his

vaccinations, that he had an immune deficiency due to his vaccinations, or that any of his

vaccinations caused any of W.R.’s neurological disorders. (Tr. 248; see also Ex. I, pp. 5-6.)

Specifically, Dr. MacGinnitie opined that there was “no evidence” in W.R.’s contemporaneous

medical records that he had an “abnormal level of inflammation or immune activation” (Ex. I, p.

5), and pointed to W.R.’s comprehensive testing of his immune system reflecting that W.R. had a

normal immune system. (Tr. 233-38; see also Ex. I, pp. 3-4.)

First, Dr. MacGinnite offered an overview of W.R.’s condition in the early years of his

life, opining that he did not consider W.R.’s routine ailments during that time period to be

reflective of an abnormal immune system, and thus effectively rebutted a major factual predicate

underlying Dr. Mikovits’ opinion in this case. (Tr. 223-38; Ex. I, p. 5.) He specifically refuted

Dr. Mikovits’ classifications of W.R.’s symptoms around the time of his first set of vaccinations

of November 19, 2008, opining that (1) he did not deem W.R.’s documented eczema at that time

to be indicative of an “autoimmune disease” (Tr. 223); (2) that there was no evidence of W.R.

having a bacterial infection at that time (id.); and (3) that Dr. Mikovits’ opinion that W.R.’s

green drainage at that time was indicative of a bacterial sinusitis had been “disproven” (id.).

Moreover, Dr. MacGinnitie pointed to W.R.’s contemporaneous medical records that reflected

that W.R.’s eczema seemed to be actually getting better by his doctor visit of August 20, 2009,

41

refuting Dr. Mikovits’ assertions that W.R.’s “eczema” was exacerbated after his first set of

vaccinations and his vaccinations thereafter. (Tr. 226; compare Ex. 19, p. 8.)

Finally, he opined that, at most, W.R.’s testing for food allergies was reflective of a

possible egg allergy, but that there was no evidence that W.R. had allergies to multiple foods, as

alleged by Petitioners in this case. (Ex. I, p. 6.) In this regard, he convincingly refuted another

major factual predicate that was important to Drs. Mikovits’ and Dr. Megson’s opinions in this

case; they alleged that W.R. had many food allergies in the early years of his life, thus indicating

an abnormal immune system. Specifically, Dr. MacGinnitie disputed Drs. Mikovits’ and

Megson’s heavy reliance on W.R.’s “patch testing” allergy results, purportedly indicating that

W.R. had a “reaction” to 17 out of 20 foods that were tested, as support for their proposition that

W.R. has many food allergies. (Tr. 239-41.) He pointed out that “patch testing” for potential

food allergies was not approved by the FDA, and convincingly discussed how testing for food

allergies is typically conducted -- typical testing that was not conducted in W.R.’s case. (Id.) In

contrast, he argued that W.R.’s patch testing results, in fact, reflect the opposite of the main

argument that Drs. Megson and Mikovits seemed to advance in this case, pointing out that if

W.R. was in fact allergic to aluminum as claimed by Drs. Megson and Mikovits, then he would

have reacted to all 20 foods on his “patch testing” due to the fact that the main apparatus used for

“patch testing” was comprised of aluminum. (Id.)

2. Jeffrey Johnson, Ph.D.

a. Qualifications

Dr. Johnson received his B.S. in Biology in 1984 and a M.S. in Pharmacology in 1986,

both from the University of Minnesota. (Ex. H, p. 2; Tr. 381.) He received his Ph.D. in

Environmental Toxicology in 1992 from the University of Wisconsin, and completed his

postdoctoral fellowship in the Department of Pharmacology at the University of Washington in

1995. (Ex. H, p. 1; Tr. 381.)

From 1995 to 1999, Dr. Johnson was an Assistant Professor within the Department of

Pharmacology, Toxicology and Therapeutics at the University of Kansas Medical Center. (Ex. H,

p. 1.) Since 1999, he has been at the University of Wisconsin-Madison School of Pharmacy,

rising to become full Professor in 2007. (Id.) Dr. Johnson has published approximately 90

medical articles in peer-reviewed journals, authored several book chapters, and has regularly

given presentations within his area of specialty. (See Ex. H.)

Dr. Johnson filed an expert report on September 28, 2015. (Ex. G.) He also testified at

the evidentiary hearing held in Washington, D.C. on February 29, 2016. (Tr. 380-438.)

b. Summary of Dr. Johnson’s opinion

Dr. Johnson systematically refuted Dr. Deth’s opinion in this case, opining that there was

“not sufficient scientific evidence” supporting Dr. Deth’s proposed link between vaccinations

and neurodevelopmental disorders, such as autism. (Tr. 417; see Ex. G generally.) Moreover, he

opined that there was no evidence that W.R. suffered from “oxidative stress” as theorized by Dr.

Deth, pointing out that, if W.R. in fact suffered from “oxidative stress,” then his clinical

symptoms would have been far worse than the symptoms W.R. currently exhibits. (Tr. 383.)

Overall, Dr. Johnson, who also testified as one of Respondent’s experts in the OAP “test cases”

42

discussed in Section II above, opined that, when laid bare, Dr. Deth was generally offering the

same theory that Dr. Deth presented as an expert on behalf of the petitioners in the OAP “test

cases” (Tr. 383) -- a theory that was thoroughly rejected.

Dr. Johnson questioned Dr. Deth’s interpretations of the underlying facts used to support

Dr. Deth’s expert theory, providing specific citations to W.R.’s contemporaneous medical

records to show that several of the statements made in Dr. Deth’s expert report were greatly

exaggerated. (Ex. G, p. 2.) Moreover, Dr. Johnson provided a detailed analysis of the medical

literature used as support for Dr. Deth’s expert opinion. (Tr. 385-411; Ex. G, pp. 4-14.) Overall,

Dr. Johnson opined that the medical literature relied upon by Dr. Deth either: (1) did not support

Dr. Deth’s theory in this case; (2) flatly contradicted Dr. Deth’s theory; or (3) were studies that

were either subsequently discredited, or had such numerous and fundamental flaws that they

there were, in essence, thoroughly unreliable. (See Tr. 388-410; Ex. G, pp. 2-4.)

In summary, Dr. Johnson concluded that Dr. Deth’s opinion in this case, which, in

essence, proposed ways that vaccinations might cause autism, was “fatally flawed.” (Ex. G, p.

14.)

3. Edward Cetaruk, M.D.

a. Qualifications

Dr. Cetaruk received his B.S. in Biochemistry from the University of Massachusetts at

Amherst in 1986, and earned his M.D. from New York University School of Medicine in 1991.

(Ex. D, p. 2; Tr. 715.) In 1994, he completed his residency in emergency medicine from the

University of Massachusetts Medical Center, and later completed his fellowship in Medical

Toxicology from the Rocky Mountain Poison Center. (Ex. D, p. 2; Tr. 715.) In 1996, he

completed a fellowship in Emergency Medicine Research at the University of Colorado Health

Sciences Center. (Id.)

Dr. Cetaruk has been an Attending Faculty Member of the Rocky Mountain Poison and

Drug Center Fellowship in Medical Toxicology since 1996, and an Assistant Clinical Professor

of Medicine at the University of Colorado Health Sciences Center since 2000. (Ex. D, p. 1; Tr.

715-16.) Starting in 2002, he has also been an Adjunct Faculty Member at Louisiana State

University’s National Center for Biomedical Research and Training. (Id.; Tr. 718.) Dr. Cetaruk,

has specialized in his career in medical toxicology, the study of the effect of potentially toxic

substances on humans, and is board-certified in that specialty. (Ex. C, p. 2; Tr. 714, 722.) Dr.

Cetaruk has also been an Emergency Medicine physician at several private hospitals throughout

his career. (Ex. D, pp. 3-4; Tr. 718.)

He has published numerous medical articles in peer-reviewed journals, authored a book

chapter, and has been invited to give several research presentations within his area of specialty.

(Ex. D, pp. 7-15.) He has also served as a manuscript reviewer for the Annals Of Emergency

Medicine and the Journal of Toxicology - Clinical Toxicology. (Id., p. 5.)

Dr. Cetaruk filed an expert report on September 4, 2014 (Ex. C), and also testified at the

evidentiary hearing held in Washington, D.C. on March 14, 2016. (Tr. 714-88.)

43

b. Summary of Dr. Cetaruk’s opinion

Dr. Cetaruk was offered as an expert in the field of medical toxicology (Tr. 723), and

primarily refuted the opinions of Drs. Shaw, Exley, and Palevsky (Tr. 727-41; see also Ex. C

generally). Dr. Cetaruk opined that there was no scientifically reliable basis for Petitioners’

theory in this case that the aluminum adjuvants in vaccinations were responsible for W.R.’s

condition. (Tr. 740.) Similarly, he opined that there was “insufficient scientific evidence to

provide a reliable scientific basis” for the theories advanced by Drs. Shaw, Exley, and Palevsky,

that there is a certain “sensitive pediatric population” that, due to underlying genetic

predispositions, “cannot detoxify and excrete aluminum,” thus leading to accumulation of

aluminum in brain tissue. (Ex. C, pp. 17-18.)

Although Dr. Cetaruk agreed with a few points made by Drs. Shaw and Exley, primarily

that aluminum had a long half-life (Tr. 733), and that a typical person would have traces of

aluminum in brain tissue (id.), he vehemently disagreed with a primary premise of Drs. Shaw

and Exley -- that there was no “safe level” of aluminum in the human body, since aluminum is

classified as a neurotoxin (id.). He explained that dosage is “very, very important in toxicology”

(Tr. 726), and that, as a general matter, aluminum “can be toxic,” but that it is a “matter of dose

and circumstance” (Tr. 734). He provided an example of the “botulinum toxin,” which,

according to Dr. Cetaruk, was the “most toxic compound known to man,” yet is a substance that

is routinely administered to humans in small doses for cosmetic purposes, primarily to reduce

wrinkles. (Tr. 726.) Thus, he explained that the tiny amount of aluminum contained in

vaccinations is not toxic (Tr. 727), and that there was no reliable medical literature stating that

the amount of aluminum exposure from vaccinations can cause aluminum toxicity in patients

(Tr. 728), or that the cumulative amount of aluminum in the typical childhood vaccination

schedule would be toxic (id.).

Moreover, Dr. Cetaruk convincingly rebutted one of the primary studies52 relied upon by

Dr. Shaw to formulate his opinion in this case -- a study which purported to show that high levels

of aluminum in patients undergoing dialysis treatment can cause a neurological condition termed

as “dialysis associated encephalopathy” (DAE). (Tr. 133-135). He pointed out that in that study

utilized by Dr. Shaw, patients on dialysis were exposed to levels of aluminum that were

“astronomically high” (Tr. 734), and thus, that study was not applicable in this case, where W.R.

received only the very tiny amounts of aluminum contained in vaccinations (id). Similarly, Dr.

Cetaruk disagreed with a major premise of Dr. Palevsky in this case -- that substances such as

aluminum contained in vaccinations can easily cross the “blood-brain barrier” to cause

neurological harm. (Tr. 736.) In this regard, he refuted one of the primary studies relied upon by

Dr. Palevsky, Ex. 319, pointing out several aspects of that study -- e.g., the study was conducted

in mice rather than humans, and had “quite high” doses of aluminum directly injected into the

brain (Tr. 738) -- that made the results of that study inappropriate as a basis for support in this

case. (Tr. 735-38.)

52

Dr. Shaw admitted at the evidentiary hearing that Petitioners had not submitted into the

record of this case that particular study, which purportedly linked very high doses of aluminum

to a condition called “dialysis associated encephalopathy” (DAE). (Tr. 134-35.)

44

4. Max Wiznitzer, M.D.

a. Qualifications

Dr. Wiznitzer earned his B.S. in Medicine in 1975 and his M.D. in 1977, both from

Northwestern University School of Medicine. (Ex. B, p. 1; Tr. 789.) He completed his residency

in pediatrics at the Children’s Hospital Center in Cincinnati in 1980, and completed his

fellowship in developmental disorders at the Cincinnati Center for Developmental Disorders in

1981. (Id.) Thereafter, he completed a fellowship in pediatric neurology at the Children’s

Hospital of Philadelphia in 1984. (Id.) In 1986, Dr. Wiznitzer completed his fellowship in

Higher Cortical Functions at Yeshiva University, Albert Einstein College of Medicine. (Ex. B,

pp. 1-2; Tr. 789-90.) Since 1986, Dr. Wiznitzer has been at Case Western Reserve University,

where he has risen to concurrently serve as an Associate Professor of Pediatrics, Neurology, and

International Health. (Id.)

Dr. Wiznitzer received a National Research Service Award from the Albert Einstein

College of Medicine in 1986, and was recognized as the Professional of the Year by the Autism

Society of Ohio in 1991. (Ex. B, p. 3.) He was certified by the American Board of Pediatrics in

1982, the American Board of Psychiatry and Neurology with special qualification in Child

Neurology in 1986, and the National Board of Medical Examiners in 1978. (Id., p. 5; Tr. 790-

91.) Dr. Wiznitzer served on the editorial board of Pediatric Neurology, Journal of Child

Neurology, and Lancet Neurology. (Ex. B, p. 6; Tr. 793.) He has co-authored 58 peer-reviewed

articles, 4 book chapters, and 55 abstracts, and has authored 7 books. (Ex. B, pp. 13-23; Tr. 797.)

He has also been invited to give hundreds of academic presentations throughout his career. (Ex.

B, pp. 23-25; Tr. 796.)

Dr. Wiznitzer filed an expert report on September 4, 2014. (Ex. A.) He also testified at

the evidentiary hearing held in Washington, D.C. on March 14, 2016. (Tr. 789-889.)

b. Summary of Dr. Witnitzer’s opinion

Dr. Wiznitzer refuted several of the expert opinions offered by the Petitioners in this case,

with a primary emphasis on rebutting Dr. Megson’s opinion. (See Ex. A and Tr. 789-890

generally.) Overall, Dr. Wiznitzer opined that there was no evidence in the contemporaneous

medical records that W.R. had adverse reactions to any of his vaccinations (Tr. 846), and that

there was “no evidence” of a “developmental regression” following his 19-month DTaP, as

claimed by Petitioners and their experts in this case (Tr. 847). Moreover, he opined that there

was no evidence that any of W.R.’s vaccines caused or contributed to any of W.R.’s

developmental disabilities (Tr. 847; Ex. A, p. 24), further opining that W.R.’s “clinical course”

was, in fact, “consistent with a developmental trajectory of ASD” (Ex. A, p. 24).

Dr. Wiznitzer offered a thorough analysis of W.R.’s contemporaneous medical records to

systematically refute several of the major underlying factual predicates upon which Dr. Megson

based her expert opinion (Tr. 803-13), and to opine that W.R.’s clinical presentation was typical

for children with an autism spectrum disorder (Tr. 813-25). Notably, Dr. Wiznitzer discussed

W.R.’s medical records from his first year of life, opining that, contrary to Dr. Megson’s

representations, W.R. showed delays in numerous developmental areas throughout that time

45

period (Tr. 800-02); and pointed to W.R.’s medical records at 18 months of age, opining that

those records reflect that W.R. was “developmentally behind” in “all spheres” at that time (Tr.

803). Moreover, Dr. Wiznitzer strongly disagreed with Dr. Megson’s opinion that W.R.

experienced “significant developmental regression” after receiving the DTaP vaccination of May

4, 2010 (Tr. 805), refuting her opinion on this critical issue by providing numerous citations to

W.R.’s contemporaneous medical records which reflected that, in essence, his developmental

skills in numerous areas were the same before and after his DTaP vaccination of May 4, 2010

(see Tr. 805-13).

Moreover, Dr. Wiznitzer discussed the statements made by Dr. Civitello, one of W.R.’s

treating neurologists in this case, who provided a medical letter, Ex. 102, which indicated that

W.R. experienced a regression contemporaneous to his vaccinations (see Ex. 102), effectively

pointing out several flaws with that letter (Tr. 813-18). Similarly, Dr. Wiznitzer refuted certain

aspects of the opinions of Drs. Ratajczak and Palevsky. In this regard, he opined that (1) Dr.

Ratajczak’s belief that the “blood-brain barrier” was not fully formed until the age of 36 months

of age, was “totally incorrect” (Tr. 832-33); (2) that Dr. Palevsky’s overall theory -- that the

human brain developed in a pattern similar to that of the “reptilian brain” -- “goes against all the

knowledge we have about brain development” (Tr. 837); and (3) that none of the references cited

by Dr. Palevsky in his expert report supported Dr. Palevsky’s theory that certain substances

contained in vaccinations, such as “polysorbate 80,” contributed to W.R.’s brain injury in any

way (Tr. 845-46).

5. Bruce Cohen, M.D.

a. Qualifications

Dr. Cohen received his A.B. in Chemistry from Washington University in 1978, and his

M.D. in 1982 from Yeshiva University, Albert Einstein College of Medicine. (Ex. F, p. 1.) He

completed his residency in pediatrics in 1984 at the Children’s Hospital in Philadelphia, and his

residency in pediatric neurology in 1987 at Columbia Presbyterian Medical Center. (Id.) He also

completed a fellowship in pediatric neuro-oncology in May 1989 at the Children’s Hospital of

Philadelphia. (Id.) From 1989 to 2011, Dr. Cohen was a Staff Physician at the Cleveland

Clinic’s Neurological Institute, serving as Chairman of Pediatric Neurology from 1999 to 2002.

(Id., p. 2.) From 1992 to 2003, he also concurrently served as an Associate Professor of

Pediatrics at the Ohio State University Department of Pediatrics. (Id.) He has been a Professor

of Pediatrics at Northeast Ohio Medical University since 2011. (Id.) Moreover, he is the current

Director of Neurology and the Interim Director of the Neurodevelopmental Science Center at the

Children’s Hospital Medical Center of Akron, in addition to being a Staff Member at the

Department of Neurology at Akron General Hospital. (Id.)

Dr. Cohen has served as a reviewer and on editorial advisory boards of 11 scientific

journals. (Ex. F, p. 3.) He has been invited to give over 600 presentations and lectures

throughout his career. (Id., pp. 5-33.) Additionally, he has co-authored 93 peer-reviewed

scientific articles, 96 abstracts, and a textbook, and has authored 30 book chapters within his area

of specialty. (Id., pp. 36-48.)

Dr. Cohen’s expert report was filed on September 28, 2015 (Ex. E), but he did not testify

at the evidentiary hearing.

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b. Summary of Dr. Cohen’s opinion

Dr. Cohen’s expert opinion in this case primarily rebutted the opinion of Petitioners’

expert Dr. Suzanne Goh, and, like Dr. Goh, he did not testify at the evidentiary hearing in this

case. (See Ex. E generally.) Dr. Cohen opined that W.R. did not have a “mitochondrial illness”

or an “ongoing mitochondrial dysfunction” (Id., p. 11), and that W.R.’s presentation of

symptoms was “most consistent with the presentations of children with autism” (Id.). Moreover,

he opined that there was “no evidence in the contemporaneous medical records of a regression

following any vaccinations.” (Id.)

VI

SUMMARY OF MY OPINION

Unfortunately, it is not completely clear exactly what Petitioners are arguing in this

case. For example, as will be detailed below, Petitioners and their experts were not even clear

as to what injuries that W.R. purportedly suffered were allegedly caused by his vaccinations.

From my careful review of this case, it seems to me that the Petitioners’ counsel and their

experts, in combination, purposefully relied upon a “kitchen sink” approach to this litigation,

offering an ever-changing litany of suggestions of different mechanisms by which W.R.’s

vaccinations might have harmed him, in the hopes that one suggestion might prove persuasive.

Moreover, the scope of Petitioners’ expert testimony seemed to shift throughout this litigation,

confounding the issues as to (1) the exact condition in W.R alleged to have been vaccine-

caused, and (2) the precise explanations as to how W.R.’s vaccinations allegedly caused those

injuries. Petitioners’ ten different experts put forward many different suggestion as to how

W.R.’s many vaccinations during his first 20 months of life might have injured him. In many

cases, those experts seemed to merely suggest possible causation theories, without any

substantial explanation, much less support, for such theories. Thus, to specifically describe,

discuss, and refute every one of the suggestions of Petitioners’ experts would take an opinion

hundreds of pages long. Nevertheless, I will, in this Decision discuss, and reject, the chief

theories propounded by Petitioners’ experts. And in this Section VI of my Decision, I will. I

outline the issues to be discussed in this Decision, and my summary of that discussion.

In this case, Petitioners seek a Program award, contending that W.R.’s neurological and

alleged immunological injuries were “caused-in-fact” by the vaccinations administered to him in

the first 20 months of his life. After thoroughly reviewing the record of this case, I have found

all of the causation theories advanced in this case to be quite unpersuasive. There are many

reasons to reject the Petitioners’ overall theory that W.R.’s vaccinations caused his neurological

deterioration and alleged immunological injuries, but I will highlight the most important here.53

53

Petitioners have the burden of demonstrating the facts necessary for entitlement to an

award by a “preponderance of the evidence.” § 300aa-13(a)(1)(A). Under that standard, the

existence of a fact must be shown to be “more probable than its nonexistence.” In re Winship,

397 U.S. 358, 371 (1970) (Harlan, J., concurring).

Petitioners’ ten different experts put forward many different suggestion as to how W.R.

many vaccinations during his first 20 months of life might have injured him. In many cases,

47

First, I note that Petitioners’ experts in this case based their causation opinions not

primarily upon the medical records, but most heavily upon additional symptoms allegedly

displayed by W.R. during his early years of life, as set forth in the affidavits of the Petitioners,

plus Mrs. Rogero’s hearing testimony. Thus, in Section VII(A), I first rule as to whether the

additional facts alleged by W.R.’s parents concerning W.R. -- i.e., those facts that do not appear

in W.R.’s contemporaneous medical records -- are accurate descriptions of W.R.’s medical

history. In this regard, I do not find, to be reliable, the written and oral testimony offered by

W.R.’s parents, alleging that W.R. suffered additional post-vaccination symptoms after each set

of vaccinations administered to W.R. in his early years of life, symptoms that are not reflected in

his contemporaneous medical records. In this regard, I emphasize that I am not questioning the

sincerity or honesty of the Petitioners. I simply find the contemporaneous medical records,

reflecting W.R.’s condition at the time his parents sought medical care during his early years of

life, to be more reliable.

Therefore, based on my rejection of the additional factual allegations made by the

Petitioners, I necessarily find that Petitioners’ experts relied on two critical misassumptions of

fact in formulating their respective expert opinions. Thus, in Sections VII(B), (C), and (D). I

discuss the critical incorrect assumptions of fact found in Petitioners’ expert opinions that render

their opinions, as a whole, to be fatally flawed, and thus wholly unreliable.

A second crucial reason, as set forth in detail at Section VIII of this Decision, is that the

qualifications of Respondent’s experts were overwhelmingly superior to the extremely weak

qualifications of Petitioners’ experts.

A third reason is that a comparison of the expert reports and expert testimony in this case

demonstrates that Respondent’s experts were far more persuasive than Petitioners’ experts. (See

Sections IX of this Decision, below.)

A fourth reason is that Petitioners’ experts failed to demonstrate the basic premise of

their causation arguments, that the tiny amount of aluminum in vaccination can cause any harm

to vaccinees. They wholly failed to show that the aluminum in W.R.’s own vaccines caused

him to suffer an “encephalopathy,” caused his autism spectrum disorder, or caused any other

harm. (See Section X, below.)

Another reason is that Petitioners’ experts failed to demonstrate another part of their

causation theory, that W.R. had an immune system disorder. (Section XI.)

Another reason is that Petitioners’ experts failed to demonstrate a different part of their

causation theory, that W.R.’s genetic variants made him more susceptible to harm by

vaccinations. (Section XII.)

those experts seemed to merely suggest possible causation theories, without any substantial

explanation, much less support, for such theories. Thus, to specifically describe, discuss, and

rebut every one of the suggestions of Petitioners’ experts would take an opinion hundreds of

pages long. Nevertheless, I will in this Decision discuss, and reject, the chief theories

propounded by Petitioners’ experts. And in this Section VI of my Decision, I will.

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Petitioners’ experts also failed to demonstrate another part of some of those experts’

theories, that W.R. had a mitochondrial disorder that allegedly made him more susceptible to

injury by vaccination. (Section XIII.)

I also conclude that a letter by a treating physician, Dr. Civitello, did not support

Petitioners’ causation theory (Section XIV); that many of Petitioners’ own experts

acknowledged the

This text is long and has been trimmed here. Open the source document for the complete record.