Doug Paluck and Rhonda Paluck, as Parents and Natural Guardians on Behalf of Their Minor Son, Karl Paluck v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

DOUG PALUCK and RHONDA *

PALUCK, as parents and natural * No. 07-889V

guardians on behalf of their minor * Judge Charles F. Lettow

son, KARL PALUCK, * Special Master Christian J. Moran

*

Petitioners, * Filed: May 10, 2013

*

v. * Entitlement; significant aggravation

* mitochondrial disorder; decision

SECRETARY OF HEALTH * on remand

AND HUMAN SERVICES, *

*

Respondent. *

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

Sheila A. Bjorklund, Lommen Abdo Law Firm, Minneapolis, MN, for petitioners;

Chrysovalantis P. Kefalas, United States Dep’t of Justice, Washington, DC, for

respondent.

PUBLISHED DECISION ON REMAND DENYING ENTITLEMENT1

Doug and Rhonda Paluck request compensation on a claim that various

vaccines harmed their son, Karl. Their case is proceeding in the National

Childhood Vaccine Injury Compensation Program. 42 U.S.C. § 300aa–10 et seq.

(2006). The statute authorizes recovery when the petitioners establish that

1

The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899,

2913 (Dec. 17, 2002), requires that the Court post this decision on its website.

Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing

redaction of medical information or other information described in 42 U.S.C.

§ 300aa–12(d)(4). Any redactions ordered by the special master will appear in the

document posted on the website.

vaccines either caused a new illness or significantly aggravated a pre-existing

condition.

A December 14, 2011 decision (“Entitlement Decision”) found that the

Palucks failed to establish that the measles, mumps, and rubella (“MMR”),

varicella, and pneumococcal vaccines caused Karl’s illness based upon a failure to

establish the factors set forth in Althen v. Secretary of Health & Human Servs.,

418 F.3d 1274 (Fed. Cir. 2005). This decision did not determine whether the

Palucks’ case should be categorized as either an initial causation claim or a

significant aggravation claim. See Decision, 2011 WL 6949326.

The Palucks filed a motion for review. On April 18, 2012, the Court granted

this motion, vacated the December 14, 2011 decision, and remanded for additional

findings. Opinion and Order, 104 Fed. Cl. 457 (2012). The Court permitted, but

did not require, the submission of additional evidence. The Opinion and Order

specified that the decision on remand should determine whether “indicia of Karl’s

neurodegeneration manifested themselves prior to the vaccinations that occurred

January 19, 2005.” Id. at 469. The Opinion and Order also explicitly stated that

the Court was “mak[ing] no affirmative findings of its own.” Id. at 484.

The parties were given an opportunity to present additional evidence on

remand. However, they did not and the evidentiary record has not changed after

the remand.

Karl manifested problems traceable to his central nervous system before he

was vaccinated. Thus, the Palucks’ claim is treated as a claim that the vaccinations

significantly aggravated his underlying mitochondrial disorder. As discussed

extensively below in sections IV.B, IV.C and IV.D, the Palucks have not

established that Karl showed the rapid and drastic effects of a vaccination as the

theory of their expert, Dr. Frye, predicted. Notably (but not exclusively), Karl’s

dramatic decline did not happen until months after the vaccination.

For these reasons, the Palucks have not demonstrated that they meet the

standards for entitlement. The Clerk’s Office is instructed to enter judgment in

accord with this decision unless a motion for review is filed.

2

I. Procedural History after Remand

After the Opinion and Order remanded the case, the first action was the

submission of an order requesting status reports from each side, proposing the next

steps in the case. The parties were also instructed to address “the Court’s

comments regarding classifying Karl’s case as either a significant-aggravation

claim or new-injury claim.” Order, filed Apr. 24, 2012.

The Palucks filed a status report containing four parts. First, the Palucks

argued that in the Opinion and Order, the Court “made specific findings as to each

Althen prong . . . . Upon his careful review of the record in this matter, [the Court]

concluded that Petitioners submitted sufficient evidence to meet their burden under

all of the three Althen prongs . . . . [The special master] needs only to adopt [the

Court’s] reasoning and conclusions.” Pet’r Status Rep’t, filed May 7, 2012, at 1.

Second, the Palucks argued that Karl’s neurodegeneration after January 19, 2005,

constituted a new injury and they were entitled to compensation on that claim. Id.

at 3-7. Third, and alternatively, the Palucks argued that even if Karl’s claim were

one for significant aggravation, they remain entitled to compensation. Id. at 7.

Fourth, the Palucks asserted that “[t]here is no need for additional testimony or

submission of evidence as to causation.” Id. at 8.

After filing an unopposed motion for enlargement of time, the Secretary

presented her response to petitioners’ status report on June 8, 2012. First, the

Secretary summarized portions of the Opinion and Order. Resp’t Resp., filed June

8, 2012, at 1-3. Next, the Secretary contended that Karl’s case is properly

classified as a significant aggravation claim and argued that the Palucks have not

established that they are entitled to compensation. Id. at 3-8. The Secretary

responded to the alternative theory, the new injury claim, in a single sentence. Id.

at 8. Finally, the Secretary stated “should the special master decide that the record

is insufficient to fully consider petitioners’ claim as one of significant aggravation,

respondent does not object to the submission of additional evidence for that

purpose.” Id.

An unrecorded status conference was held on June 27, 2012. As set forth in

the subsequent order, the parties were informed that their status reports did not

answer a question posed by the Court. The Opinion and Order expected resolution

of whether “Karl’s neurological, not mitochondrial, symptoms, however defined,

were manifested pre-vaccination.” The undersigned commented that the Secretary

appeared to have lumped Karl’s neurological problems with Karl’s mitochondrial

problems, which was contrary to how the Court framed the issue. The undersigned

3

also requested that the Palucks explain how Karl’s gross motor delay that was

found in October 2004, differed from the chiropractor’s report of hypertonicity and

spasticity in February 2005. Consequently, both sides were ordered to file

supplemental briefs. Order, filed July 10, 2012.

The Secretary filed a supplemental brief on August 21, 2012.2 Consistent

with her previous briefs, the Secretary continued to press the argument that, as a

legal matter, Karl’s claim should be analyzed as a significant aggravation claim. In

the Secretary’s view, Karl suffered one continuous process in which his

“neurodegeneration . . . developmental delays, and related symptoms are a sequela

of Karl’s pre-existing mitochondrial disorder.” Resp’t Br., filed Aug. 21, 2012, at

1. The Secretary asserted that neurological symptoms are not separate from

mitochondrial symptoms. Id. at 3. On the topic of mitochondrial disorders, the

Secretary stated that she had “no objection to re-opening the record to provide

additional evidence on mitochondrial disorders.” Id. at 3 n.1.

The Palucks responded. The Palucks argued that “Karl had no

neurodegeneration prior to his receipt of vaccine on January 19, 2005.” Pet’r Br.,

filed Aug. 28, 2012, at 2 (capitalization changed without notation). The Palucks

reviewed some of the evidence showing Karl’s pre-vaccination history. Id. at 2-5.

The Palucks interpreted this evidence as consistent with their legal claim that the

January 19, 2005 vaccinations caused him a new injury. Id. at 5-7. In conclusion,

the Palucks argued against additional evidence. They stated:

It would be a waste of resources in both time and money for this Court

to open the record in this matter to receive additional evidence on

mitochondrial disorders as suggested in a footnote by Respondent.

See Respondent’s Suppl Brief, fn 1. There is more than sufficient

testimony and medical literature as a matter of record to permit this

court to make a determination if this is a cause-in-fact injury case or a

significant aggravation injury case.

Id. at 7.

2

The Secretary had informally requested additional time to file this brief due

to an injury to her attorney. The Palucks did not oppose this request. See order,

filed July 30, 2012.

4

An August 30, 2012 order permitted the Palucks to identify evidence that

Karl’s gross motor delay was caused by a problem in his muscles, as opposed to

his central nervous system (“CNS”). The Palucks responded on September 4,

2012.

An unrecorded status conference was held on September 11, 2012. A

primary purpose was to ascertain the Secretary’s position regarding the need for

additional evidence. In previous filings, the Secretary had stated that she did not

object, but the Secretary had not requested additional evidence. In the ensuing

status report, the Secretary stated that she “will not at this time move to present

additional evidence on the question of whether Karl’s pre-vaccination

mitochondrial symptoms were central nervous system or musculoskel[e]tal

problems.” Resp’t Status Rep’t, filed Sept. 18, 2012, at 2. The next day, the

Palucks stated that “[t]his matter is ripe for decision.” Pet’r Status Rep’t, filed

Sept. 19, 2012, at 2.

At the oral argument on the second motion for review, which is discussed

below, the parties confirmed that they did not want to present additional evidence:

THE COURT: Was there a consensus between the parties that

no further evidentiary proceedings were to be conducted on remand

before the Special Master?

[PETITIONER’S COUNSEL]: Yes. Both sides were provided

the opportunity to identify whether or not they believe[d] that further

hearings were required or further evidence was required to be

submitted into the record, and clearly Petitioners determined that there

was sufficient evidence in the records to meet our burden of proof.

Oral. Arg. Tr., April 10, 2013, 9:1 to 10:3.3

In combination, the Court’s Opinion and Order; the April 24, 2012 order,

requesting “next steps;” and the September 11, 2012 order, requesting statements

regarding the need for additional evidence presented the parties with several

opportunities to obtain additional evidence. The attorneys saw the Court’s

instructions about the need for the special master to consider, among other topics,

3

Later, on this point, the Court commented that he “has been a little

surprised that there weren’t further evidentiary proceedings conducted before the

Special Master, but I’ll leave that aside.” Id. at 24:6-8.

5

the chiropractor’s records. The attorneys, presumably, reviewed those records and

the testimony from the experts about those records. This process “afford[ed] each

party a full and fair opportunity to present its case.” Vaccine Rule 3(b)(2). After

an opportunity to consider whether additional information would be helpful, each

party submitted status reports declaring that additional evidence was not needed.

The parties submitted the case for adjudication.4

4

Conceivably, the undersigned could have exercised his authority to

“require the testimony of any person,” 42 U.S.C. § 300aa – 12(d)(3)(B)(iii), sua

sponte. As a matter of discretion, the undersigned refrained for several reasons.

First, the attorneys of record are experienced and competent counsel. They are

able to analyze the law and the facts. The attorneys also have access to doctors

who can informally advise them as to whether additional evidence may help (or

hurt) their cases. Thus, there is little reason for this special master to second-guess

the informed decision of the parties not to submit additional evidence, especially

because special masters have been cautioned not to interfere with counsel’s

development of the case. See Boley v. Sec’y of Health & Human Servs., 82 Fed.

Cl. 407, 414 (2008), mot. for rev. denied after remand, 86 Fed. Cl. 294 (2009).

Second, as a practical matter, a sua sponte order requiring the testimony of a

medical doctor would be difficult to implement. A basic question is who would

pay for the doctor’s time? In this time of budget austerity, this question matters.

This issue alone may account for why special masters have not issued any sua

sponte orders compelling unrequested testimony during the undersigned’s tenure as

a special master.

Third, the compelled testimony of a witness implicates other relationships.

For example, the Palucks may have a continuing relationship with Karl’s primary

pediatrician, Dr. Stephen McDonough, who may wish not to become involved in

litigation. Thus, the Federal Circuit has warned that “the specter of a subpoena”

could be “a disincentive” for doctors “to treat a vaccine-injured patient.” Andreu

v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1383 (Fed. Cir. 2009).

For these reasons, special masters guide parties in presenting their cases and

are willing, when the circumstances justify an order, to compel the production of

evidence that a party has requested. See, e.g. Doe 34 v. Sec’y of Health & Human

Servs., 87 Fed. Cl. 758, 765 (2009) (ruling that special master did not err in

securing participation of a doctor whose testimony the Secretary “had always

requested”). After the parties present all their evidence, the special master

functions as a finder of fact, albeit one with expertise in the subject. See Hodges v.

Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). One party’s

disappointment over the outcome of a hearing does not entitle that party another

(. . . continued)

6

On October 8, 2012, the Palucks filed a second motion for an award of

attorneys’ fees on an interim basis. After the parties discussed the request, the

Palucks filed a stipulation on October 22, 2012. The next day, a decision awarding

additional attorneys’ fees was entered.

On January 30, 2013, the Palucks filed a motion for review with the Court,

arguing that the undersigned’s time for issuing a decision expired 90 days after the

April 18, 2012 Opinion and Order. After additional briefing and argument, the

Court denied the motion for review, finding that the amount of time that case was

pending on remand did not constitute “such a passage of time as undue delay

tantamount to a failure to exercise jurisdiction on the part of the special master.”

The Court mandated a decision within 120 days of its May 3, 2013 Opinion and

Order.

II. Background of Karl’s Medical History

Although the parties draw different conclusions from the facts, there is a

basic agreement about them. These facts were detailed in the December 14, 2011

decision and the April 18, 2012 Opinion and Order. The following summary is

presented for context. More detailed findings of fact are made throughout sections

III. and IV. below.

Karl was born on January 15, 2004. His development appeared to be normal

for the first six months or so. During this time, Karl received typical vaccinations

at two, four, and six months, without any apparent ill effects from them. See

exhibit 5 at 12.

Karl’s pediatrician, Dr. McDonough, noticed that Karl was developmentally

delayed during an examination when he was eight months old. Exhibit 5 at 111.

The doctor referred Karl to a program for children with developmental delays,

K.I.D.S. The staff at K.I.D.S. assessed Karl. The ensuing report stated:

Karl’s gross motor delays are impacting his ability to achieve age-

level skills in other areas of development. Karl has difficulty moving

against gravity, which is an important gross motor foundational skill.

opportunity to present further evidence. Sword v. United States, 44 Fed. Cl. 183,

190-91 (1999) (ruling that the special master did not abuse her discretion in

denying the respondent’s motion to submit additional expert testimony).

7

. . . When evaluating Karl’s muscle tone the passivity in his arms is

greater than normal. His arm’s consistency is softer than normal and

his extensibility provides no resistance to passive movement. . . . Karl

has difficulty bringing his hands together to clap or bang cubes

together. He does not yet participate in turn-taking games such as pat

a cake and peek-a-boo. . . . In order to provide stability in his arms

and trunk, Karl fixes his legs. By fixing his legs, Karl presents with

slight elevated tone.

Exhibit 15 at 4.5

Additionally, the evaluators observed that “Karl is not using many gestures,”

and “is not approximating sounds made by another person. He tends to produce

sounds spontaneously, but does not imitate when a model is provided him.”

Exhibit 15 at 4-5. The evaluators also noted that “Karl does not respond to specific

words or phrases such as ‘no, no, Karl.’” Id. at 5. The report recommended that

Karl “receive infant development services . . . targeting his speech/language, gross

motor, and the delays in fine motor related to low muscle tone.” Id.

In this proceeding, the Palucks and the Secretary draw very different

conclusions from the K.I.D.S. report. The Palucks interpreted the report as

showing that Karl’s cognition and language abilities were “absolutely normal,” and

that any developmental delays “were most prominently gross motor delays, maybe

a little bit of fine motor delays.” Tr. 101:9-11. The Secretary, on the other hand,

saw the report as supporting her view that Karl’s cognition and language were

below average. To the Secretary, Karl’s inability to respond to “no no,” for

example, was not a “minor trivial thing.” Tr. 787:11-13.

5

The report’s authors define the following three terms: “Passivity refers to

the amount of flapping of the child’s hand or foot when the evaluator shakes an

extremity, thereby imposing multiple quick stretches. Normally the extremity

tightens at the wrist or ankle after a few excursions of the hand or foot.” Exhibit

15 at 4 n.1. “Consistency refers to the relative firmness of muscle tissue, which is

evaluated by palpation. Normally the muscle feels sturdy but there is some

yielding to pressure.” Id. at 4 n.2. “Extensibility refers to the capacity of a muscle

to elongate when a quick stretch is imposed on it. . . . Typically a normal, graded

resistance is felt throughout the range of motion.” Id. at 4 n.3

8

Around this same time, Karl was having two other problems. He was having

recurrent otitis media and recurrent erythema multiforme.6 These problems

continued to afflict Karl periodically from approximately October 2004 to April

2005. Karl was seen by his doctors for these two problems as necessary.

On December 27, 2004, Dr. McDonough saw Karl. Dr. McDonough

recorded that “[n]eurologic examination reveals normal muscle tone. There is no

ankle clonus. Deep tendon reflexes appear to be symmetrical. He has good head

control and fairly good truncal control but is not pulling himself to stand or

crawling yet.” Exhibit 3 at 5. His assessment of Karl was “[b]ilateral serous otitis

media; rash, possible erythema multiforme, . . . and possible mild gross motor

delay.” Id. at 5-6.

Karl’s next appointment with Dr. McDonough was on January 19, 2005,

which was his one-year well-baby appointment. Karl received doses of the

measles, mumps, and rubella vaccine, the pneumococcal vaccine, and the varicella

vaccine. Dr. McDonough recorded a history about Karl’s current functioning. At

this appointment, Dr. McDonough referred Karl to physical and occupational

therapy. Exhibit 3 at 3. Instead of taking Karl to a therapist as their pediatrician

recommended, the Palucks brought him to a chiropractor. Exhibit 12.

On March 24, 2005, Dr. McDonough referred Karl, then 14 months of age,

to a pediatric neurologist, Dr. Siriwan Kriengkrairut, “for gross motor delay, global

developmental delay, and hypertonicity.” Exhibit 3 at 7. In his referral, Dr.

McDonough also noted that Karl “has had recurrent erythema multiforme.” Karl

saw both Dr. McDonough and Dr. Kriengkrairut in April. See Exhibit 3 at 9-11

(Dr. McDonough), 83-85 (Dr. Kriengkrairut).

Karl had relatively little interaction with health care providers in May and

June 2005. On July 12, 2005, Karl had a series of seizures. He was hospitalized

for approximately three weeks. Despite investigation, the doctors did not identify

the cause of Karl’s seizures.

6

Erythema multiforme is “an acute eruption of macules, papules, or

subepidermal vesicles presenting a multiform appearance.” Stedman’s Medical

Dictionary 667 (28th ed. 2006). While “the eruption is usually self-limited . . . ,

[it] may be recurrent or may run a severe course.” Id.

9

After the July 2005 hospitalizations, Karl was tested extensively.

Eventually, samples obtained from Karl were sent to Baylor College of Medicine

for mitochondrial diagnostic testing. Exhibit 18 at 60-61. The electron transport

chain enzymes test conducted on muscle tissue by Baylor showed increased citrate

synthetase activity, “suggesting mitochondrial proliferation, which can be an

adaptive response to mitochondrial function.” These results, while “not

reflect[ing] any specific diagnostic pattern,” do “fulfill a minor diagnostic criterion

for a mitochondrial disorder,” id. at 60, indicating that Karl most likely suffered

from a disorder in his mitochondria. The precise nature of Karl’s mitochondrial

problem, however, is not known. See Tr. 503:22-25 (Dr. Snodgrass: “I think he

has a progressive disease and that it’s probably a primary mitochondrial disease,

but it might be a progressive disease that is not a primary mitochondrial disease.”);

Tr. 88:24-25 (Dr. Frye: “Using the modified Walker criteria or the Morava criteria,

he meets criteria for a probable mitochondrial disorder . . . he is rated as probable

by both criteria.”).

Mitochondria are organelles (parts of cells) that supply energy to cells.

“Mitochondrial disease is not a single entity but, rather a heterogenous group of

disorders characterized by impaired energy production due to genetically based

oxidative phosphorylation dysfunction. Together, these disorders constitute the

most common neurometabolic disease of childhood.” Opinion and Order, 104 Fed.

Cl. at 463 n.8, quoting Entitlement Decision, at *1, quoting exhibit E (Richard H.

Haas et al., Mitochondrial Disease: A Practical Approach for Primary Care

Physicians, 120 Pediatrics 1326, 1327 (2007)) (internal quotation marks omitted).

“Mitochondrial diseases are usually progressive and multisystemic. Typically

affected organs are those with a high energy demand, including skeletal and

cardiac muscle, . . . and the central nervous system.” Exhibit E (Haas) at 1327.

Although Karl’s treating doctors have not identified the exact error in Karl’s

mitochondria, both testifying experts agree that Karl suffers from a mitochondrial

disease. Tr. 88:23-89:2 (Dr. Frye), 413:1-20 (Dr. Snodgrass); see also Tr. 27:10-

11 (Petitioners’ attorney: “[a]n undisputed fact from both experts is that Karl has a

mitochondrial dysfunction”). Additionally, and importantly, the experts also agree

that Karl was born with his mitochondrial defect. Tr. 80:24-81:8 (Dr. Frye), 260:5-

10, 377:7-11 (Dr. Snodgrass). The fact that Karl was born with the mitochondrial

disorder means that the Palucks cannot claim (and do not claim) that any

vaccination caused Karl’s mitochondrial disorder.

Instead, the Palucks argue that “Karl’s devastating neurological regression

following receipt of five vaccines on January 19, 2005 is a new injury.” The basis

10

for this argument is that, to the Palucks, Karl “exhibited no signs of central nervous

system damage, with resultant neurodegeneration, until after receipt of the January

2005 vaccines.” Pet’r Status Rep’t, filed May 7, 2012, at 2.

The Secretary disagrees. The Secretary argues that the Palucks’ “claim is

best analyzed as a significant aggravation claim.” For the Secretary, Karl’s

“neurodegeneration, developmental delays, and related symptoms are a sequela of

Karl’s pre-existing mitochondrial disorder.” Resp’t Resp., filed June 8, 2012, at 4.

This is the first issue requiring resolution.

III. Initial Causation or Significant Aggravation

The Court’s framing of this issue controls the analytical structure on remand.

See 42 U.S.C. § 300aa–12(e)(2)(c) (empowering the Court of Federal Claims to

remand “to the special master for further action in accordance with the court’s

direction”); Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630

(1998) (a decision from the Court of Federal Claims is binding on a special master

in the same case on remand), aff’d, 191 F.3d 1344 (Fed. Cir. 1999). In its Opinion

and Order, the Court stated:

A related second issue [7] is whether indicia of Karl’s

neurodegeneration manifested themselves prior to the vaccinations

7

The Court’s initial issue was “the precise definition of Karl’s injury.” The

Court, as set forth in the text, queried whether “neurodegeneration” is the

appropriate metric. Both before and after remand, the parties have presented

evidence and argument based upon a claim of “neurodegeneration.” For examples

of pre-remand arguments, see Pet’r Posthr’g Br., filed Feb. 18, 2011, at 28

(sequence of medical events “support [petitioners’] contention that [Karl’s]

vaccines cause[d] [his] neurodegeneration”); Resp’t Posthr’g Br., filed Feb. 18,

2011, at 43 (arguing petitioners’ evidence “is irrelevant to a hypothesis that posits

a relationship between vaccinations and neurodegeneration”). For examples of

post-remand arguments, see Pet’r Status Rep’t., filed May 7, 2012, at 7 (all the

evidence “clearly demonstrates that Karl Paluck suffered a new injury –

devastating neurodegeneration – following receipt of his . . . vaccines”); Pet’r Br.,

filed Aug. 28, 2012, at 7 (“[Karl] had neurogeneration after receipt of the . . .

vaccines.”); Resp’t Br., filed Aug. 21, 2012 (“There is no reliable evidence . . . that

neurodegeneration . . . represent[s] distinct, new injuries from [Karl’s]

(. . . continued)

11

that occurred January 19, 2005. The parties have framed these issues

in simplified terms, i.e., whether Karl was progressing or regressing

developmentally prior to his vaccinations. With a genetic abnormality

of the type inhering in Karl, this may not be the proper focus for

determination. Rather, based on the record as it stands, voluminous as

it may be, it is medically and scientifically uncertain whether

developmental progress or regress is a valid measure to assess the pre-

vaccination condition of a very young child with Karl’s type of

mitochondrial defect, or whether another indicator should be

employed. If Karl’s neurological, not mitochondrial, symptoms,

however defined, were manifested pre-vaccination, then Karl’s case

involves a significant-aggravation claim. See [Shalala v.]

Whitecotton, 514 U.S. [268,] 274 [(1995)]. If not, then Karl’s case

concerns a new-injury claim.

Opinion and Order, 104 Fed. Cl. at 469. The critical portion of this passage is the

Court’s statement that “If Karl’s neurological, not mitochondrial, symptoms,

however defined, were manifested pre-vaccination, then Karl’s case involves a

significant-aggravation claim.” This statement directs an examination of Karl’s

health before vaccination, looking for evidence of “neurological, not

mitochondrial, symptoms.”8

mitochondrial disorder.”). Thus, this decision will continue to use the parties’

characterization of Karl’s injury as one of “neurodegeneration.”

8

The Court’s phrase “neurological, not mitochondrial, symptoms, however

defined” seems to distinguish neurological symptoms from mitochondrial

symptoms. See orders, filed July 20, 2012 and July 30, 2012 (requesting

supplemental briefs on this topic).

The Secretary stated that differentiating between neurological symptoms and

mitochondrial symptoms “is contrary to the medical understanding of

mitochondrial disorders, as well as contrary to the testimony of both parties’

experts.” According to this argument, “one cannot separate ‘mitochondrial

symptoms’ from the symptoms related to the mitochondrial disorder-affected

organs, including the central nervous system.” Resp’t Br., filed Aug. 21, 2012,

at 3.

The undersigned cannot entertain the Secretary’s argument. The Court’s

Opinion and Order has presented the issue as whether “Karl’s neurological . . .

symptoms . . . were manifested pre-vaccination, then Karl’s case involves a

(. . . continued)

12

The Court’s framing of the issue, however, is not how the parties presented

their cases before the remand. Consequently, there is relatively little evidence

directly responsive to the Court’s issue. From a transcript that runs more than 800

pages, each party identified only one passage in which an expert opines whether

Karl was displaying neurological symptoms before vaccination.

The Secretary points to the following portion of cross-examination

testimony as evidence in which Dr. Snodgrass opined about Karl’s pre-vaccination

neurological problems:

Q: . . . And in fact I believe you testified that his developmental

delay began sometime in the fall of 2004. That would be – the

neurologic system is a system of the body, correct?

A: It is.

Q: And the fact that he had developmental delay would indicate

that he has some type of involvement of his neurologic symptoms – or

his neurologic system.

A: His nervous system is abnormal, we can all agree on that.

***

Q: Well, he also has his muscle – musculoskeletal system

involved, does he not?

A: I believe that is secondary to the central nervous system

problem.

Tr. 416:10 to 417:22 (cited in Resp’t Br., filed Aug. 21, 2012, at 3-4).

In contrast, the Palucks cited to this excerpt from Dr. Frye’s testimony.

With reference to the K.I.D.S. evaluation of Karl in October 2004, Dr. Frye

testified:

A: . . . And the Vineland was used to look at his overall

development, it can be used as an IQ, and we see that he actually was

absolutely normal on the Vineland also without any delays. So really

this points to the specific delays in gross motor, probably due to

problems with muscle development, and the energy that the muscle

needs, because of his mitochondrial disorder.

significant aggravation claim. . . . If not, then Karl’s case involves a new-injury

claim.” This instruction is binding on remand. See Hanlon, 40 Fed. Cl. at 630.

13

Tr. 636:5-12 (cited in Pet’r Br., filed Aug. 28, 2012, at 3, and Pet’r Status Rep’t,

filed Sept. 4, 2012, at 1).

In sum, the basic dispute over whether Karl had symptoms of a neurological

problem before vaccination is captured in those two passages. Dr. Snodgrass

testified the Karl’s gross motor delays identified in the fall of 2004 were

“secondary to the central nervous system problem.” Tr. 417:21-22. Dr. Frye’s

different view is that the gross motor delays were because of a problem “with

muscle development, and the energy that the muscle needs, because of his

mitochondrial disorder.” Tr. 636:10-12.

These are the only passages in which the experts touch upon whether Karl

displayed signs or symptoms of a disorder in his central nervous system before the

vaccinations, although the record contains other relevant evidence, discussed

below. After the parties filed briefs that were intended to identify evidence

supporting their position regarding the onset of Karl’s neurological problems, a

status conference was held. The parties were informed that the quantum of

evidence on this particular topic was relatively sparse. Thus, consistent with the

Court’s statement that the case was “remanded to the special master for further

proceedings,” the parties were invited to consider whether they wished to present

additional evidence. Both parties declined. The Palucks stated “It would be a

waste of resources in both time and money for this Court to open the record in the

matter to receive additional evidence on mitochondrial disorders. . . . There is more

than sufficient testimony and medical literature as a matter of record to permit this

court to make a determination if this is a cause-in-fact injury case or significant

aggravation injury case.” Pet’r Br., filed Aug. 28, 2012, at 7.

As explained in the September 11, 2012 status conference, special masters

may decide an issue even when there is relatively little evidence (or even no

evidence) on the topic. King v. Sec’y of Health & Human Servs., No. 03-584V,

2008 WL 1994968, at *3 (Fed. Cl. Spec. Mstr. Feb. 7, 2008) (special masters “can

always rule on a factual issue no matter how scanty the evidence is, even in the

absence of any evidence. . . if there is no evidence, the factual issue simply is

resolved against the party having the ‘burden of proof’”). The special master’s

responsibility is to make findings of fact based upon the evidence and weighing

that evidence. The evidence of record need only preponderate in one party’s favor.

It is not necessary for a party to submit a certain quantum of evidence to prevail.

Under the preponderance of evidence standard, it is enough that the special master,

as trier of fact, simply “‘believe that the existence of a fact is more probable than

its nonexistence before [he] may find in favor of the party who has the burden to

14

persuade the [judge] of the fact’s existence.’” Moberly v. Sec’y of Health &

Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (quoting Concrete Pipe &

Prods. of Cal., Inc. v. Constr. Laborers Pension Trust for S. Cal., 508 U.S. 602,

622, 113 S.Ct. 2264, 124 L.Ed.2d 539 (1993)) (alterations in Moberly, further

citations omitted).

Here, the evidence preponderates in the Secretary’s favor. Before

explaining why it is more probable that Karl displayed problems in his central

nervous system before the January 2005 vaccinations, the undersigned must

acknowledge that the Palucks could be correct. It is certainly possible that Karl’s

problem in gross motor skills was purely a problem in his muscles and not at all in

his CNS. Based on this record, no one can say for sure. But, even in the absence

of certainty, the evidence must preponderate one way or the other–either Karl’s

gross motor problems originated with his CNS or they did not.9

Three reasons support a finding that Karl was manifesting problems with his

CNS before 2005. First, indisputably, Karl was displaying poor muscle tone. The

connection between CNS and muscle tone appears not to be particularly

controversial, as Dr. Frye testified, in the context of explaining what tone is, “[t]he

nervous system helps maintain tone.” Tr. 111:19-2010; see also Tr. 109:6-7 (Dr.

9

The outcome of this issue does not depend on how the burden of proof is

allocated. The burden of proof determines which party prevails when the evidence

is in equipoise. See Andrew Corp. v. Gabriel Electronics, Inc., 847 F.2d 819, 824

(Fed. Cir. 1988); Cook v. United States, 46 Fed. Cl. 110, 113 n.5 (2000); see also

Director, OWCP v. Greenwich Collieries, 512 U.S. 267, 272-76 (1994) (discussing

difference between burden of persuasion and burden of producing evidence).

Here, the evidence is not in equipoise. The evidence preponderates in favor of the

Secretary’s position.

10

At this point in his testimony, Dr. Frye had been asked to explain the

significance of “truncal hypotonia,” a symptom that a neurologist detected in Karl

in April 2005, months after the vaccination. Dr. Frye stated that truncal hypotonia

“is suggesting that we have brain damage that is going on, or it also could be

muscular damage, too. . . . It would be more damage to the nervous system.” Tr.

111:16-20.

Given this context, Dr. Frye’s testimony that “[t]he nervous system helps

maintain tone” is viewed as supporting the limited proposition that problems in

(. . . continued)

15

Frye: “with increased tone, you think that there’s damage to the cortex of the brain

or the white matter”).

Dr. Frye’s acknowledgement of a connection between low muscle tone and

dysfunction in the CNS tends to make it more likely that Karl’s tone was due to a

CNS disease. But, this general likelihood is not the only reason for finding that

Karl exhibited neurological symptoms before his January 2005 vaccinations.

The second reason supporting a finding that Karl was displaying problems

originating in his central nervous system in the fall 2004 was that Karl was having

trouble with functions other than just his gross motor skills. According to the

K.I.D.S. report that assessed Karl’s functioning, Karl had a problem with his

expressive language. Exhibit 15 at 2-3.

While the Palucks steadfastly argue that before the January 2005

vaccinations, Karl “had normal central nervous system functioning,” Pet. Br., filed

Aug. 28, 2012, at 7, this argument is not persuasive. The Palucks are overlooking

the portion of the K.I.D.S. report that recommended Karl should receive

developmental services “targeting his speech/language.” Exhibit 15 at 5.11

A problem in expressive language tends, at least in the absence of other

identified causes, to be considered a CNS problem.12 Dr. Snodgrass’s testimony

tone sometimes originate in the nervous system. Tr. 111:19-20. Dr. Frye did not

say all problems in muscle tone come from the nervous system.

11

When questioned about this referral, Dr. Frye stated that the K.I.D.S.

evaluators’ referral for speech therapy was “probably [a] more protective

prophylactic measure[].” Tr. 722:14-15. However, there is no evidence—other

than Dr. Frye’s opinion—to support the assertion that the K.I.D.S. evaluators were

not proposing a therapy intended to help Karl. The recommendation that Karl

receive speech therapy is in line with his performance on the PLS-3 and Vineland,

showing that Karl was 22 percent delayed in communication skills. A more

detailed discussion of Karl’s expressive language in October 2004 is found in

section IV.A.2 below.

12

In one unrecorded status conference, the Palucks’ attorney suggested that

Karl may have had a problem with his expressive language because he could have

had a misshapen tongue. The Palucks have not offered this explanation in any of

(. . . continued)

16

alludes to this connection between expressive language and CNS. On direct

examination, Dr. Snodgrass testified that prior to Karl’s vaccination – in

September and October of 2004 – his “development was abnormal in speech and

language and both gross and fine motor function were impaired.” Tr. 328:5-6. On

cross examination, Dr. Snodgrass testified that Karl’s “nervous system is

abnormal” and that his pre-vaccination developmental delays indicated the

involvement of his neurologic systems. Tr. 416:15-19.

Again, it should be pointed out that, as a matter of logic, it is possible that

(a) Karl had gross motor delays exclusively because the mitochondria in his

muscles (and only in his muscles) were not functioning, and (b) Karl had delays in

his expressive language for unidentified reasons unrelated to his CNS.

Conceivably, there could be two (or more) unrelated processes preventing Karl

from developing normally in the domains of gross motor and express language.

However, the question is what is more likely? It seems much more likely that

Karl’s mitochondrial defect was already starting to affect his central nervous

system before the January 2005 vaccinations. Mitochondrial defects can impair

the functioning of organs with a high need for energy, such as the central nervous

system. Exhibit E (Haas) at 1327.

Finally, and least importantly, the Palucks and Dr. Frye made evidentiary

admissions that are consistent with a finding that Karl’s case is one for significant

aggravation. For example, the Palucks’ October 17, 2008 Amended Petition stated

that they allege that the “vaccines given on January 19, 2005 caused a significant

aggravation of Karl’s underlying mitochondrial disorder, leading to alterations in

his brain development and subsequent neurodevelopmental regression.” Amended

Pet., filed Oct. 17, 2008, at 2. The Secretary’s post-remand brief specifically cited

this pleading, Resp’t Resp., filed June 8, 2012, at 4-5, and the Palucks have not

explained why they should not be held to their attorney’s statements. See Pet’r Br.,

filed Aug. 28, 2012.

Similarly, the Secretary cited a portion of Dr. Frye’s testimony that supports

the Secretary’s view that Karl’s case is one of significant aggravation. Dr. Frye

stated: “I believe that [it] is more likely than not that the vaccines received on

January 19, 2005, significantly changed the course of Karl’s development by

their written briefs and the Palucks have not identified any evidence that supports a

finding that Karl’s developmental delay in regard to expressive language was

based upon a structural problem.

17

significantly exacerbating an underl[y]ing mitochondrial disorder.” Resp’t Br.,

filed Aug. 21, 2012, at 2 (citing Tr. 53:9-12).13

Dr. Frye’s use of the term “significantly exacerbating” in his testimony and

the Palucks’ use of the term “significant aggravation” in their amended petition

further support a finding that Karl’s case should be characterized as one of

significant aggravation, although these comments are not dispositive by

themselves. In the Vaccine Program, special masters typically do not strictly hold

petitioners to their pleading.14 Similarly, not too much weight is given to Dr.

Frye’s isolated statement referring to “significantly exacerbating.” On the other

hand, to the extent that the amended petition and Dr. Frye’s testimony have

relevance, they weigh, slightly, on the side of significant aggravation.

For these reasons, the preponderant weight of the evidence favors finding

that Karl was displaying neurological problems before vaccination.15 Thus,

according to the structure set by the Court’s Opinion and Order, Karl’s case is

properly analyzed as presenting a claim for significant aggravation.

13

In the same paragraph of the Secretary’s brief, she cites other portions of

Dr. Frye’s testimony for the proposition that “Dr. Frye often characterized Karl’s

post-January 2005 condition in terms that suggested a connection to all his

symptoms.” Resp’t Br., filed Aug. 21, 2012, at 2. However, in the cited portions

of Dr. Frye’s testimony, he seems to be comparing Karl’s condition in April or

June 2005 to Karl’s condition in January 2005, not Karl’s condition in October

2004.

14

In traditional litigation, parties are bound by their pleadings. See, e.g.,

Best Canvas Prods. & Supplies, Inc. v. Ploof Truck Lines, Inc., 713 F.2d 618, 621

(11th Cir. 1983) (stating that as a general rule “a party is bound by the admissions

in his pleadings”) (citations omitted).

15

The undersigned has also considered the relative experience of Dr. Frye

and Dr. Snodgrass. Both have some experience with mitochondrial disorders, but

neither has extensive experience. For Dr. Frye’s background in mitochondrial

disorders, see Tr. 42:25 to 46:20, 210:16 to 213:2. For Dr. Snodgrass’s experience,

see Tr. 250:11-14, 396:4 to 400:12, 495:2-4, 554:13-55:7. Thus, this factor does

not contribute to accepting or to rejecting either Dr. Frye’s opinion or Dr.

Snodgrass’s opinion.

18

IV. Significant Aggravation

The elements of an off-Table significant aggravation case were stated in

Loving v. Secretary of Health & Human Servs., 86 Fed. Cl. 135 (2009).16 There,

the Court blended the Althen test, which defines off-Table causation cases, with a

test from Whitecotton, which concerns on-Table significant aggravation cases.

The resultant test has six components. These are:

(1) the person’s condition prior to administration of the vaccine, (2)

the person’s current condition (or the condition following the

vaccination if that is also pertinent), (3) whether the person’s current

condition constitutes a ‘significant aggravation’ of the person’s

condition prior to vaccination, (4) a medical theory causally

connecting such a significant worsened condition to the vaccination,

(5) a logical sequence of cause and effect showing that the vaccination

was the reason for the significant aggravation, and (6) a showing of a

proximate temporal relationship between the vaccination and the

significant aggravation.

Loving, 86 Fed. Cl. at 144; see also Opinion and Order, 104 Fed. Cl. at 468, n.14

(citing and quoting the Loving test).

Since Loving was decided, the Federal Circuit has explained that possible

alternative causes may be considered as part of a petitioner’s prima facie case. See

Stone v. Secretary of Health & Human Servs., 676 F.3d 1373, 1380 (Fed. Cir.

2012). To maintain clarity in parts of the analysis, the possibility of alternative

causes is set out in a separate section below. See section V.

Of the six parts to the Loving test, the December 14, 2011 decision

addressed factors four through six because those elements overlap with the Althen

test. Although the Court accepted this method of analysis, the Court vacated the

decision with respect to each of the Althen elements. The Court’s analysis of

factors four through six is discussed extensively in the context of the particular

element. However, factors one through three have not been specifically analyzed

16

After remand, the Federal Circuit approved the Loving six-prong test as

accurately setting forth the elements of petitioners’ case. W.C. v. Sec’y of Health

& Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013).

19

in either the December 14, 2011 decision or the Court’s Opinion and Order. Hence

Loving factors one through three begin the analysis.

A. Loving Prong 1: What was Karl’s Condition Prior to

Administration of the Vaccine?

The first step in the Loving test is to define Karl’s condition before he

received the vaccinations at issue. An overarching problem is that Karl was born

with a mitochondrial defect, although the doctors treating Karl before the

vaccinations did not know of this defect.

The parties agree that Karl’s mitochondrial defect was affecting his

development before vaccination. The Palucks maintain that the mitochondrial

defect was isolated to Karl’s muscles and this mitochondrial defect caused Karl to

have delays in his gross motor development that was recognized in October 2004.

See Pet’r Br., filed Aug. 28, 2012, at 3 (“Dr. Frye explained that the delays noted

in this October 2004 evaluation [referring to the K.I.D.S. assessment] were

secondary to problems with Karl’s muscle development and energy needs because

of his undiagnosed medical disorder.”). Thus, the Palucks recognized that the

mitochondrial disorder was impairing Karl’s health, but disputed linking the

mitochondrial disorder to Karl’s CNS.

The Secretary agreed that Karl’s mitochondrial disorder was already being

manifested in the fall 2004. Resp’t Br., filed Aug. 21, 2012, at 1 (“Karl’s

mitochondrial symptoms, including neurological symptoms, manifested before his

receipt of his January 2005 vaccinations.”). As discussed in the preceding section,

a preponderance of evidence supports the finding that the mitochondrial problem

impaired the functioning of Karl’s CNS.

To determine the state of Karl’s condition prior to vaccination, it is

necessary to examine his medical records and the experts’ testimony on various

aspects of his health and development. The following sections discuss his illnesses

and immunologic responses, expressive language skills, and the extent of his gross

motor problems. On the second and third topics, the experts have some

disagreements.

1. Illnesses and Karl’s Immunologic Responses

As the Court stated “[d]uring this same time period [before vaccination],

Karl began manifesting two medical problems that would appear repeatedly from

20

October 2004 to July 2005: otitis media and erythema multiforme.” Opinion and

Order, 104 Fed. Cl. at 462 (footnotes deleted without notation). Exhibit 3 at 38,

57-62. The erythema multiforme indicates that Karl’s immune system was

activated. Tr. 98:8-12, 295:2-14.

On October 14, 2004, Karl was examined by Dr. Amy E. Oksa, who

recorded an impression of bilateral otitis media, viral exanthema, and left

conjunctivitis. Dr. Oksa prescribed Amoxicillin for the ear infection, Gentamicin

ophthalmic solution for the conjunctivitis, but no specific treatment for the rash.

The Palucks were encouraged to return to the clinic in “two to three weeks for

recheck [of the rash] and sooner if needed.” Exhibit 3 at 57.

On November 8, 2004, Karl was seen by Dr. Donna J. Mumert at the

Dickinson Clinic. The physician reported that Karl “has a history of otitis media.

Mom states that she’s not sure that he’s getting better and would like to have his

ears rechecked.” Karl’s mother also reported that he had been “fussy over the past

couple of days.” Dr. Mumert recorded an impression of left otitis media and

prescribed Zithromax to be administered daily for five days. She recommended

that Karl be rechecked in one week or sooner. Exhibit 3 at 58.

On November 15, 2004, Karl returned to the Dickinson Clinic and was

examined by Dr. Oksa, who recorded that Karl presented for an ear recheck,

having “had bilateral otitis media initially treated with amoxicillin one month ago

and then treated with Zithromax one week ago. He currently seems to be doing

well.” Ms. Paluck also recounted that Karl “still has been fussy and irritable.” Dr.

Oksa’s impression was that the otitis media had resolved. Under “Plan,” the report

notes “Flu shot today.” Exhibit 3 at 59.

On December 4, 2004, Karl visited the Dickinson Clinic for a recheck and

was examined by Dr. Mumert. The report states that Karl

was on Zithromax two weeks ago for an ear infection. He did have an

ear recheck following this. His ears were clear. However, mom states

he has been fussy over the past couple of days. . . . Mom states that for

the last week he has been irritable and not his usual self. He has not

had any fevers. No diarrhea. He is otherwise healthy and well.

Exhibit 3 at 60. After examining Karl, Dr. Mumert recorded an impression of

bilateral otitis media. She also noted that Karl’s skin was “[n]ormal with no

21

exanthem.” Id. She prescribed Omnicef for 10 days and recommended that Karl

be rechecked in two weeks or sooner. Id.

Karl returned two weeks later, on December 11, 2004, to be examined by

Dr. Oksa. In her report, Dr. Oksa wrote that “Karl presents today for evaluation of

skin lesions on his arms and legs. Patient has had these for greater than one week.

Of note, he had a similar type rash October 14, 2004, when evaluated for bilateral

otitis media and conjunctivitis.” Exhibit 3 at 61. Dr. Oksa continued:

Mother states that this rash went away, but developed again about a

week ago. . . . The fussiness was better, but now has worsened over

the last couple of days. He also developed a very slight papular rash

on trunk earlier this week, but it was much different than the

extremity rash and has pretty much gone away. It was not urticarial.

Mother could barely perceive it. It had been noticed by the day care

provider. The Omnicef was stopped . . . three days ago, secondary to

more of the rashes.

Id. Dr. Oksa’s examination revealed “several 0.5 to 1.0 centimeter areas of

erythema which are slightly raised, but nontender. These are present mostly

on the distal extremities, but there are also a couple of lesions on the

proximal upper extremities.” Id. She observed that “[s]ome are more

purplish in appearance. No petechiae or purura noted.” Id. Dr. Oksa

recorded an impression of “[r]esolved otitis media” and “[p]robable

erythema multiforme secondary to viral illness.” She prescribed Orapred

and recommended a return to the clinic if the symptom persisted or

worsened. Id.

On December 22, 2004, Karl presented at the Dickinson Clinic for a recheck

of his rash. Dr. Oksa recorded that Karl’s “[m]other states that the spots almost

totally resolved. The only lesions that were left were slightly bluish resolving

lesions. After the Orapred was finished the red spots came back and now . . . are

worse than . . . before.” Exhibit 3 at 62. Dr. Oksa reported “[a]pproximately 1.0

centimeter erythematous, slightly raised vesicular lesions on extremities, more on

the distal lower extremities than proximal and mostly on the distal upper

extremities. The rest of the skin is spared.” Id. Her impression was a recurrent,

nonspecific rash. Dr. Oksa’s plan was to “discuss patient with Dr. Cornatzer,

Dermatology, and proceed with whatever recommendations he has.” Id.

22

The Palucks brought Karl to Dr. Cornatzer, a dermatologist, on December

27, 2004. Dr. Cornatzer obtained a biopsy from Karl’s left arm. The results of the

biopsy were consistent with the diagnosis of erythema multiforme. See exhibit 9 at

1-3.

Karl’s erythema multiforme presents a potential alternative cause for Karl’s

neurodegeneration (as the Palucks have defined Karl’s neurodegeneration).

Although Dr. Frye acknowledged that Karl suffered from erythema multiforme

before vaccination, this condition did not affect Dr. Frye’s opinion. See Tr. 626:19

to 628:6 (redirect). However, Dr. Snodgrass questioned the consistency of Dr.

Frye’s position. Dr. Snodgrass queried if Dr. Frye were correct that Karl’s

neurodegeneration started when Karl’s immune system was activated, why didn’t

the erythema multiforme start that process? In Dr. Snodgrass’s view, if Dr. Frye

were correct on his theory, the erythema multiforme (and not the vaccinations)

could have caused the aggravation. See Tr. 357:16 to 358:17 (direct examination);

see also Tr. 443:16-19 (cross examination). Resolution of this question is not

necessary because, as explained below, Karl did not significantly decline in the

weeks immediately following January 19, 2005, when he both received a set of

vaccinations and suffered another bout of erythema multiforme.

2. Expressive Language

One point of departure between the experts regarding Karl’s pre-vaccination

condition is his expressive language. The primary source of information about

Karl’s ability to use language is the K.I.D.S. evaluation in October 2004.17 Karl’s

language was evaluated using three tests, the Bayley Scales of Infant Development

2nd Edition, the Preschool Language Scale-3 (“PLS-3”), and the Vineland

Adaptive Behavior Scales. Exhibit 15 at 2.

Bayley. On this test, Karl’s “MDI” was 91.18 An MDI score of 91 is the

age equivalent of eight months. Since Karl was a few days past nine months old at

17

Dr. McDonough’s January 19, 2005 evaluation adds additional

information about Karl’s language. This report is discussed in the following

section.

18

In this context, “MDI” probably means “mental development index.”

Medical Abbreviations (15th ed. 2011) at 204.

23

the time of the evaluation, this represented a delay of 11 percent. Nevertheless, he

was classified as “Within Normal Limits.” Exhibit 15 at 2.

Vineland. In the “Communication Domain” of the “Adaptive Behavior

Composite” for the Vineland, Karl’s standard score was 94. This placed Karl in

the 34th percentile with an age equivalency of 7 months. The amount of his delay

in communication was 22 percent. Exhibit 15 at 3.

PLS-3. Karl’s performance on the Vineland’s Communication Domain was

quite similar to his score on another standardized test the K.I.D.S. evaluators gave

to him, the Preschool Language Scale-3. “The PLS-3 evaluated Karl’s ability to

use language (language expression) and understand language (auditory

comprehension).” Exhibit 15 at 2. For “Expressive Communication,” Karl’s

standard score was 101, which placed him in the 53rd percentile. His age

equivalent was “7 months,” again making him 22 percent delayed. Id. at 3. Dr.

Snodgrass briefly addressed the PLS-3, agreeing with petitioners’ counsel that it

placed Karl at the seven month level. Tr. 459:20 to 460:1.

In Dr. Frye’s opinion, Karl’s “language was right at the average.” Tr. 100:5.

Dr. Frye based his opinion on the PLS-3. Dr. Frye stated that Karl’s “total

language standardized score was 96. The average is 100, but 96 is very close to

100 on these scales, and so he was very close to normal as far as his language.” Tr.

100:5-8.

In this context, Dr. Frye also discussed the result of Karl’s performance on

the Vineland Adaptive Behavior Scales. Dr. Frye stated, “As far as what normal

development would be considered, that his delays were most prominently gross

motor delays, maybe a little bit of fine motor delays, but cognition, language was

absolutely normal.” Tr. 101:8-11; see also exhibit 15 at 3 (reporting results of

Vineland).

Additionally, Dr. Frye testified that he viewed the PLS-3 as unnecessary

because Karl passed the Denver II test19 at one year of age. Dr. Frye explained that

the Denver test “is a screening test . . . to tell you to go for more specific tools such

as the PLS or the PDMS. And really more specific tools like [these] shouldn’t

really necessarily be used unless you fail some screening tests.” In this case Karl

19

See sub-section IV.A.3.b., below, for a description of the Denver II and

Karl’s results on the test.

24

“actually passed the Denver[,]” which “suggests that he doesn’t need any of those

tests at one year of age.” Tr. 822:17 to 823:4.

When asked whether Dr. Frye was correct in assessing Karl as “right at the

average” in his language, Dr. Snodgrass said that Dr. Frye was not correct. Dr.

Snodgrass explained why he thinks that Karl’s language was not at the average.

Dr. Snodgrass testified that

the evaluation included a number of things and it included the fact that

Karl did not seem to respond to ‘no’. Now no is a pretty elementary

communication. And he did not mime or copy sounds made by

others. Before we can speak normally, small babies will make noises

similar to a noise which their caretaker is making.

Tr. 329:5-12. Dr. Snodgrass did acknowledge that Karl scored within

normal limits on the Bayley test. Tr. 459:16-19.

When Dr. Snodgrass was asked whether Dr. Frye’s statement from transcript

page 101 that “cognition language was absolutely normal” was true, Dr. Snodgrass

said, “I think if we refer to Exhibit 15 we’d have to say no that’s not correct.” Tr.

329:16-17.

During redirect, Dr. Frye essentially repeated his opinion that the October

2004 K.I.D.S. evaluation showed that Karl’s “language was completely normal.”

Tr. 636:1-2. Dr. Frye also stated that “he actually was absolutely normal on the

Vineland also without any delays.” Tr. 636:7-8. The Palucks’ attorney did not ask

Dr. Frye to address Dr. Snodgrass’s testimony on page 329 of the transcript.

The undersigned, however, requested that Dr. Frye address the difference in

his opinion expressed on page 99 of the transcript and Dr. Snodgrass’s opinion

from page 329. Dr. Frye was referred to four skills relating to language that the

K.I.D.S. evaluators said that Karl could not perform. Dr. Frye was told that Dr.

Snodgrass pointed to some of these deficiencies as supporting Dr. Snodgrass’s

opinion that Karl was delayed in language. Dr. Frye responded: “But I don’t think

that’s correct because . . . the objective standardized test put him absolutely in the

average range.” Tr. 722:9-11.

Dr. Frye also questioned the consistency of the K.I.D.S. evaluation. Dr.

Frye noted that one of Karl’s listed weaknesses was not communicating with

25

gestures. However, one of Karl’s identified strengths was “gestur[ing] for ‘I

want.’” See Tr. 723:9-25; see also exhibit 15 at 3, 5.

There was a brief rejoinder from Dr. Snodgrass when he testified later that

day. Dr. Snodgrass stated that “things like not responding to no no was significant,

it was more than just a minor trivial thing.” Tr. 787:11-13.

When the K.I.D.S. evaluators identified problems with Karl’s gross motor

skills and expressive language, they referred him for therapy “targeting his

speech/language, gross motor, and the delays in fine motor related to low muscle

tone.” Exhibit 15 at 5. If the Palucks accepted this referral for treatment, then the

notes are not contained within exhibit 15.

While the Palucks argue that Karl’s language development was normal, as

measured by the various tests performed in October 2004, it seems unlikely that

the evaluators would have referred Karl to therapy targeting his speech and

language if this were the case. Accordingly, the preponderant weight of the

evidence favors finding that Karl’s language development was delayed prior to his

vaccination.

3. Extent of Gross Motor Problems before Vaccination

Another area of difference between Dr. Frye and Dr. Snodgrass concerns

Karl’s physical function on the day he received his vaccinations, January 19, 2005.

In short, Dr. Frye saw Karl as relatively well, except for some motor delay. In

contrast, Dr. Snodgrass’s viewed Karl as worsening.

Dr. Snodgrass’s opinion rests upon Dr. McDonough’s records from

appointments on December 27, 2004, and January 19, 2005. Thus, those two notes

are detailed below. Following those summaries, the competing perspectives of the

experts are set forth.

a) Developmental Status on December 27, 2004

During the appointment during which Dr. Cornatzer biopsied Karl’s rash,

Dr. Cornatzer recommended that Dr. McDonough see Karl because Karl had been

pulling on his ears. See exhibit 3 at 5. This was on December 27, 2004, 23 days

before the date of vaccination. See exhibit 23 at 7-8. Dr. McDonough recorded a

developmental history that “Karl is rolling over. He tries to crawl, he has several

words that he says.” In Dr. McDonough’s assessment of Karl’s neurologic system,

26

he records the following good traits about Karl: “normal muscle tone. There is no

ankle clonus. Deep tendon reflexes appear to be symmetrical. He has good head

control and fairly good truncal control.” On the other hand, Dr. McDonough also

states Karl “is not pulling himself to stand or crawling yet.” Dr. McDonough

assessed Karl as having “possible mild gross motor delay,” but did not refer Karl

for therapy or otherwise mention whether Karl was receiving services through the

K.I.D.S. program. Dr. McDonough intended to check Karl at his next visit in one

month. Exhibit 3 at 5-6.

b) Developmental Status on January 19, 2005

The next appointment, a well-baby visit to assess Karl at one year of age,

occurred on January 19, 2005. In the history of present illness section, there is a

notation that Karl is not standing. The HPI section also states “recheck rash.”

Exhibit 5 at 62.

For the “Growth & Development” section, there is a circle around “Roll

Over” and “Babbles,” skills associated with a six month old. Next to the words

“Sit well” and “Pull to Stand,” abilities associated with an eight month old, is the

hand-written notation “not.” For nine months category, the form lists “Crawl”

“Wave bye” “Dada-Mama.” Of these three, only “Crawl” is circled with

handwriting saying “4 point.” For the 11-12 months category, the form lists

“Cruise / Roll Ball,” “Use cup / Pincer” and “1-3 words.” None of these items is

circled. Beside the “Use cup / Pincer” skill is handwriting noting “not yet.” An

additional handwritten note in another portion of the form states “doesn’t hold cup

well.” Handwriting next to “1-3 words” is difficult to decipher, but appears to say

“no words.” Exhibit 5 at 62.

Another assessment of Karl’s abilities is presented on a Denver II

(“Denver”) screening form. Exhibit 5 at 35. (The Palucks and Dr. Frye filed a

blank Denver screening form to assist in understanding the typical development,

because Karl’s form is faded, making it difficult to read. See exhibit 38.) The

Denver evaluates four different domains (personal/social, fine motor adaptive,

language, and gross motor), which are distributed along the screening form’s

vertical axis. Across the form’s horizontal axis, top and bottom, are marks

designating the age of the child, from birth to 6 years of age. During an evaluation,

the evaluator aligns a ruler with the marks printed on the top and bottom of the

form corresponding to the child’s age and draws a vertical line through the form.

This line intersects with specified age-appropriate skills printed on the form in

each of the four domains. Dr. Frye explained how the form is used.

27

If you look in the upper left hand corner you see what seems to be a

scale, it says percentage of children passing and it goes from 25 to 50

to 75 to 90. . . .

This is important because as long as this line that’s drawn . . . is

within that shaded bar we know that it’s within normal limits. . . .

[T]he way we use the Denver . . . we go through the four different

areas, that is personal/social, fine motor adaptive, language, and gross

motor, and we ask whether a child can do these skills or can’t do these

skills. And if th[e] line that we’ve drawn is outside one of those

boxes and the child can’t do that [skill], we get concerned.

. . . the way we notate this usually is if the child can do an

activity we put P for pass, if they can’t we put F for fail. . . .

***

. . . if their chronological age passes through that box that

means they should have developed or be developing that skill. It’s not

until their chronological age actually passes the box that you say that

they should have done it and they’re not or that they’ve actually failed

that developmental milestone.

Tr. 631:10 to 633:22.20

Within the personal - social domain, Dr. McDonough assigned Karl three

“P’s” (for passing) and two “F’s” (for failing). The passing abilities were “initiate

activities,” “play ball with examiner,” and “indicate wants.” The failing skills

were “wave bye-bye” and “play pat a cake.” For both these activities, more than

75 percent of children can do them by 12 months. On the other hand, “initiate

activities” and “play ball with examiner” seem to be activities performed by less

than 75 percent of children.

Within the domain of “fine motor - adaptive,” there is one “P” that is near

two different skills, “bang 2 cubes held by hands” and “thumb finger grasp.” Both

of these activities can be accomplished by 99 percent of children at 11 months.

The next domain is “language.” Dr. McDonough has an “F” for “one word”

and a “P” for “dada-mama specific.” The “dada-mama specific” skill is something

20

Dr. Snodgrass did not disagree with Dr. Frye’s explanation. See Tr.

799:11-17 (“Well I think he is reiterating what the developers of the Denver would

say.”).

28

approximately 75 percent of children can accomplish by approximately 11 months.

For the “one word” skill, about 50 percent of children can do this by 12 months,

with 75 percent of children speaking one word at 14 months.21

The final domain is “gross motor.” There are two “P’s” for “stand holding

on” and “pull to stand.” Approximately 75 percent of children can pull to stand at

approximately 9 months and approximately 99 percent can pull to stand at

approximately 10 months. Karl’s form also has three “F’s” in gross motor. Of

these three skills that Karl was not displaying, the most basic step is “get to

sitting.” The normal values for “get to sitting” is about the same as “pull to stand,”

with about 75 percent of children getting to sitting at nine months and 99 percent

getting to sitting at 10 and 1/2 months. The other two skills in the gross motor

domain marked with F’s are “stand 2 secs,” and “stand alone.” There was no mark

for two skills that fewer than 50 percent of children can do at 12 months: “stoop

and recover” and “walk well.”

There are some slight inconsistencies in the recording of Karl’s abilities

between the two forms. For example, on the form from Dr. McDonough’s office,

the entry for “Dada-Mama” around 9-10 months is not circled. Exhibit 3 at 3. Yet,

on the Denver form, Karl got a “P” for “dada-mama specific.” Similarly, Dr.

McDonough did not circle, but wrote the word “not” next to “Pull to stand” under

7-8 months, whereas there is a P on the Denver form next to “pull to stand.”

Dr. McDonough’s office form also has a section in which the pediatrician

can report the results of a physical examination. Most systems were “WNL”

(within normal limits). There are two exceptions. First, the entry for “Hips” is

checked WNL, but there is a handwritten notation saying “got [illegible] ↓ROM.”

See Tr. 825:9-19, 829:12 to 831:6, 331:6 (interpreting notation to indicate a

decreased range of motion). Second, the entry for “Neuromuscular” is checked as

ABN (abnormal). The handwriting says “muscle tone ↑+ upper.” The entry

appears to continue on the next line, saying “lower extremities.” A third line reads

“2 Beats clonus R [illegible]. A fourth line reads, perhaps, “inconsistent.”

Dr. McDonough’s assessment includes “gross motor delay” and “recurrent

erythema multiforme.” The plan was an “early development referral [to]

Dickinson.” The Dickinson Clinic offered “> [greater] available PT OT [physical

21

Dr. Frye explained that doctors usually do not count a child’s speaking

“dada” or “mama” as a spoken word. Tr. 748:4-13.

29

therapy and occupational therapy] services.”22 Dr. McDonough also prescribed

Zithromax. He wanted Karl to return in 3 months. Exhibit 3 at 3.

c) Testimony

The testifying experts came to different conclusions about Karl’s functioning

as of January 19, 2005. Dr. Frye’s initial direct testimony discussed Karl’s status

on the date of vaccination relatively cursorily. The extent of the dialog between

the Palucks’ attorney and Dr. Frye was:

Q: Then if we move to January of 2005 at his 12-month and

four days past his 12-month birthday, he received the MMR, PCV7,

and Varicella. At that evaluation for those – and at the receipt of

those vaccines, his pediatrician did note that he was going to refer

Karl for possible, again, motor delay.[23]

A: Right.

Q: And specifically those gross motor delays were as you were

just describing. He wasn’t able to sit totally unsupported, and he was

not yet crawling or pulling himself to a stand.

A: Exactly.

Tr. 102:16 to 103:4. At this point, the Palucks’ attorney begins questioning Dr.

Frye about Karl’s fevers following the vaccinations.

In Dr. Snodgrass’s preliminary24 direct testimony, he also briefly discussed

Karl’s status in January 2005. Dr. Snodgrass stated that Karl worsened between

22

In a later record, Dr. McDonough specified that on January 19, 2005, he

referred Karl for “physical and occupational therapy in Dickinson” and

recommended a “stimulation program and ongoing tracking” with “Badland

Human Services.” Exhibit 3 at 7.

23

Although counsel’s question says that Dr. McDonough was referring Karl

for “possible” motor delay, Dr. McDonough referred Karl for motor delay. Exhibit

3 at 3. Unlike Dr. McDonough’s December 27, 2004 report, the January 19, 2005

report does not characterize Karl’s gross motor delay as “possible.”

24

The first day of the hearing was March 22, 2010. During that session, the

Palucks’ attorney requested that Dr. Snodgrass testify on direct examination before

(. . . continued)

30

his visits with Dr. McDonough on December 27, 2004, and January 19, 2005. In

the earlier appointment, Dr. McDonough recorded that Karl “‘says words.’” Tr.

257:14 (quoting exhibit 3 at 5). However, in the next month, Dr. McDonough

“says, ‘No words, doesn’t sit well.’” Tr. 257:14-15 (quoting exhibit 5 at 62). To

Dr. Snodgrass, “something was changing in that relatively short interval, a bit less

than a month.” Tr. 257:18-19.

When the hearing resumed, Dr. Snodgrass returned to the differences in Karl

between December 2004 and January 2005. Dr. Snodgrass commented that in

December 2004, Dr. McDonough said that “Karl doesn’t pull to stand or crawl.

That his development is abnormal but that his tone, muscle tone, is normal.” Tr.

330:22-24; accord exhibit 3 at 5. To Dr. Snodgrass, Dr. McDonough’s finding that

Karl has normal muscle tone in December 2004 is important because on January

19, 2005, Dr. McDonough found that “Muscle tone of the extremities and the back

is up or increased and there’s ankle clonus on one side.” Tr. 331:7-9.25 In Dr.

Snodgrass’s view, Karl was worse in January than he was in December: “These

are new findings which were not present in December. This [ankle clonus] is a

positive finding if you have abnormal tone, whereas beforehand, the findings were

simply that Karl could not do things which the average child would do at that age.”

Tr. 331:10-14.

Dr. Frye did not rebut Dr. Snodgrass’s opinion that between December 2004

and January 2005, Karl worsened. Dr. Snodgrass pointed to two deteriorations.

First, Karl went from “says words” to “no words.” Second, Karl went from

“normal muscle tone. . . . [with] no ankle clonus,” exhibit 3 at 5, to “muscle tone

[increased]” with “2 beats clonus” on his right side, exhibit 5 at 62. Thus, there is

preponderant evidence that in two areas of development – gross motor and

the Secretary cross-examined Dr. Frye. This request was denied and the hearing

proceeded in a more traditional format with cross-examination of Dr. Frye

immediately following his direct examination. See Tr. 134:1 to 141:2. The

duration of Dr. Frye’s testimony and Dr. Snodgrass’s travel commitments limited

Dr. Snodgrass’s direct testimony on March 22, 2010, to a short amount of time.

25

Dr. Snodgrass also interpreted Dr. McDonough’s handwriting as saying

that Karl had a “decreased range of hip motion.” Tr. 331:6. This portion of Dr.

McDonough’s record is not easily deciphered.

31

expressive language – Karl was worse in January than he was the previous

month.26

Dr. Snodgrass’s opinion that Karl was deteriorating in December 2004

accords with statements made by Ms. Paluck during Karl’s hospitalization in July

2005. When Karl was hospitalized, Ms. Paluck told four people (Dr. Oska (a

physician at St. Joseph’s Hospital); Molly Eastman (a nurse practitioner, working

26

Some testimony compared Karl’s gross motor ability in January 2005 to

his gross motor ability in October 2004. Dr. Frye stated that Karl’s gross motor

ability in October 2004 was the equivalent of a four month old. Since Karl was

nine months old in October 2004, the amount of delay was five months. Tr. 639:6-

9. In January 2005, Karl’s gross motor development was between nine and ten

months, making his delay two to three months. Tr. 639:13 to 640:6. So, in Dr.

Frye’s opinion, Karl’s gross motor functioning had improved between October and

January because “he was a little bit less delayed.” Tr. 638:24.

Dr. Snodgrass stated that attempting to give Karl an overall level of

functioning was not helpful.

I’ve got a problem with the whole Denver concept of reducing gross motor

to X months. Karl had asymetrical motor performance. There were a

number of areas where his performance was quite bad. . . .

So the problem is you can take a thing he does badly and a

thing he does well and average them, but that doesn’t really give you a

useful answer. In other words I wouldn’t want to reduce his gross

motor impairment to a single area[,] but I would say his gross motor

performance was bad, I’d certainly say that.

Tr. 802:18 to 803:6; see also Tr. 458:21-24 (Dr. Snodgrass: “What we have for

Karl is that in some areas his problem was greater than in others. So trying to

reduce him to a single age equivalent of eight months is, I believe, misleading.”).

Comparing Karl in October 2004 to Karl in January 2005, while interesting,

is not very illuminating. The K.I.D.S. testing was a “very good and extensive

evaluation.” Tr. 99:2 (Dr. Frye); accord Tr. 328:20-24 (Dr. Snodgrass agreeing

with Dr. Frye’s testimony on transcript page 99). Training is required to

administer the standardized tests given to Karl as part of the K.I.D.S. testing. Tr.

821:17-21 (Dr. Frye); see also Tr. 786:10-15 (Dr. Snodgrass). In contrast, the

Denver screening test “is a quick screening test, it’s not a detailed evaluation.” Tr.

786:8-9.

32

with Dr. Frost); Dr. Pierpont (a geneticist); and Dr. Moertel (a hematologist)) that

Karl’s problems started in the fall 2004. See Tr. 360:3 to 367:2 (Dr. Snodgrass)

(citing exhibit 6 at 62-65; exhibit 11 at 225, 229-32, 234; and exhibit 11 at 46).

Two of those reports say that Karl began to lose milestones at 11 months.

Since Ms. Paluck was recounting in July 2005 Karl’s status in December

2004, her recollection is not truly contemporaneous. See Shapiro v. Sec’y of

Health & Human Servs., 101 Fed. Cl. 532, 539 (2011) (discussing

“contemporaneous”), aff’d without opinion, No. 12-5152 (Fed. Cir. May 7, 2013).

On the other hand, Ms. Paluck was providing her statement when she was seeking

treatment to solve Karl’s medical problem and her statement was not made when

she was anticipating litigation. Furthermore, as Dr. Snodgrass testified without

any contradiction, the medical personnel who created these records obtained the

history from Ms. Paluck independent of each other and they are consistent with

each other. Thus, these histories are entitled to some consideration, see Cucuras v.

Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993), even if

they are not dispositive by themselves. See Tr. 646:6-7 (Dr. Frye stating that he

“rel[ies] very heavily on care giver information”).

Overall, by January 19, 2005, Karl had problems in his CNS. His

pediatrician diagnosed him with gross motor delays, which had worsened in the

preceding three weeks. Karl was also having problems with his language. Finally,

Karl was recovering from the most recent episode of erythema multiforme.

B. Loving Prong 2: What is Karl’s Current Condition (or His

Condition Following the Vaccination, if Also Pertinent)?

The second part of the Loving test is to discuss “the person’s current

condition (or the condition following the vaccination if that is also pertinent).”

While both periods are included in the Court’s test, an analysis of Karl’s most

current condition is not possible, as the Palucks have not filed recent medical

records.27 Accordingly, the analysis under this prong will focus solely on Karl’s

health in the months following his vaccination.

27

The Palucks’ counsel, without submitting any medical records, presented

some information about Karl’s health during the April 10, 2013 oral argument on

the second motion for review. She stated that Karl was recently hospitalized but

has returned home. He requires a ventilator to breathe and his parents have

implemented a do not resuscitate order. He remains unable to perform basic life

(. . . continued)

33

The December 14, 2011 decision discussed Karl’s post-vaccination status as

part of the second Althen prong. That decision concluded that between September

2004 and July 2005, Karl’s developmental progress was “not linear.” Decision,

2011 WL 6949326, at *23. The Court’s Opinion and Order vacated this aspect of

the December 14, 2011 decision primarily because it failed to discuss records of a

chiropractor whom Karl was seeing. Opinion and Order, 104 Fed. Cl. at 480.

For ease of organization, Karl’s history is divided into periods, roughly

corresponding to the source of information about Karl.

1. Daycare Records

The first post-vaccination record created contemporaneously with the events

being described in it is a record from Karl’s daycare.28 For January 21, 2005, there

is an entry stating that “Deb [presumably a staff member at FunShine Express] talk

[sic] to Rhonda [Karl’s mother] about chiropractor.” The daycare record also

states that Karl had a temperature of 101.5 degrees. Exhibit 22 at 1.

A daycare staffer made additional entries on January 24, 25, and 26, 2005.

On these three days, Karl was recorded as being “fussy.” However, there is no

notation or other indication that Karl had a fever on any of those days. On January

28, 2005, Karl is again recorded as being “very fussy,” but the caregiver also states

that Karl had a fever of 101.3. Exhibit 22 at 2.

sustaining activities such as eating and swallowing. He receives nutrition through

a feeding tube. See Oral Arg. Tr., April 10, 2013, at 34:16 to 35:20.

28

The Palucks filed two pages of records from Karl’s daycare provider,

FunShine Express. These two pages contain entries beginning on January 6, 2005

and ending on February 8, 2005. Exhibit 22.

During the earlier phase of the case, the undersigned ordered the Palucks to

produce other records from Karl’s daycare. Order, filed July 22, 2011. The

Palucks filed a status report, stating “there are no other daycare records to be

obtained and, therefore, none to be submitted.” Pet’r Status Rep’t., filed Aug. 22,

2011.

34

The experts discussed the significance of the fever on these two days and the

other symptoms, such as tiredness, that the daycare providers recorded.29 Dr. Frye

29

The Court questioned whether it was appropriate to find that Karl had

fever only on these two days. The Court stated “[r]easoning from . . . omissions to

a positive postulate is always questionable.” Opinion and Order, 104 Fed. Cl. at

476, n.27 (citations and quotation marks omitted).

The finding that Karl did not have a fever on days other than January 21 and

January 28, however, is consistent with how the parties presented their cases. In an

October 27, 2009 status conference, the parties discussed the extent of Karl’s

fevers. The undersigned had inquired if a hearing to determine facts about Karl’s

condition were needed. The Palucks’ attorney represented that the presence of a

fever does not make a difference to Dr. Frye’s opinion because he saw evidence of

an encephalopathic process whether or not Karl had a fever. Ultimately, in the

October 27, 2009 status conference, the parties agreed that although there may be a

genuine dispute about whether Karl’s fevers were “high,” this was a non-material

fact. In light of this agreement, the undersigned did not order a fact hearing.

Although the October 27, 2009 status conference was not recorded, the

extent of the agreement was memorialized at the beginning of the hearing. Tr.

8:18-25. Although both counsel commented upon the undersigned’s description of

the fever issue, the attorneys did not argue that Karl had a fever on days other than

January 21 and January 28. Tr. 11:19 to 12:18.

In their post-hearing brief, the Palucks referred to Karl as having a fever on

January 21 and January 28. Their recitation of facts included:

Karl developed a fever of 101.5°F. on January 21, 2005. From

January 21st through 28th, his day care providers noted Karl to be

lethargic, irritable, tired, and to have a decreased appetite. They

recorded a fever of 101.3°F on January 28, 2005. There was no

indication that Karl was ill prior to receiving his vaccines on the 19th

or was otherwise ill during the January 21-28 time frame.

Pet’r Posthr’g Br., filed Feb. 18, 2011, at 6 (citations omitted and emphasis added).

If the Palucks intended to contend that Karl had a fever on days other than

January 21 and January 28, it was incumbent on them to offer persuasive evidence

supporting this contention. See Walther v. Sec’y of Health & Human Servs., 485

F.3d 1146, 1150 (Fed. Cir. 2007) (“[I]t would be unusual to require a party to

prove that ‘there is not a preponderance of evidence,’ as our legal system rarely

requires a party to prove a negative.”). In absence of this showing, the undersigned

(. . . continued)

35

testified “He was lethargic. He was irritable. He was tired, had a decreased

appetite, so he had systemic signs of being sick or of, as we had talked about,

immune activation, these immune mediators actually being increased, and possibly

this process already going on of this cascade of metabolic decompensation.” Tr.

103:23 to 104:3. To Dr. Frye, Karl’s irritability and lethargy was a manifestation

of an encephalopathic process. Tr. 193:10-25. As part of cross-examination, Dr.

Frye explained that the vaccines activated Karl’s immune system and the activated

immune system produced a fever. Tr. 196:25 to 197:3.

Dr. Snodgrass agreed that Karl’s daycare reported a fever on two days. Dr.

Snodgrass testified that the varicella and MMR vaccines, which contain live

viruses, “do cause a fever in some children, but it takes time to appear. And it

usually will not appear until the seventh or eighth day.” Tr. 338:23 to 339:1. Dr.

Snodgrass disagreed with Dr. Frye’s causal connection of Karl’s January 2005

vaccinations and his subsequent fever. Dr. Snodgrass stated that “a fever two days

after immunization is unlikely to be due to those immunizations.” Tr. 339:1-2.30

Even though Karl had a fever on two days in January, Dr. Snodgrass stated

that Karl was, overall, healthier than he was a few months earlier. Dr. Snodgrass

stated “there is a contrast between November and December 2004 when there were

many doctor visits and phone calls and January and February when there were

not.” Tr. 336:19-22. In this same portion Dr. Snodgrass reiterated:

[W]e have this marked contrast between November and December

when he was often seeing the doctors, either in Bismarck or at the

Dickinson Clinic or his parents were telephoning them.

So I have every reason to believe that his parents are attentive

to his needs, so I have to conclude that he was more sick in November

and December than he was in January or February.

Tr. 341:22 to 342:5. More evidence of Karl’s relatively improved state of health is

that the rash, which had been episodically recurring in Karl throughout the fall

finds that in the two weeks following vaccine, Karl had a fever only on those two

dates.

30

On cross-examination, Dr. Snodgrass elaborated about the basis for his

opinion that fevers occurring shortly after an MMR or varicella vaccination are not

caused by the vaccine. See Tr. 570:20 to 576:20.

36

2004, was better on January 19, 2005. Tr. 445:9-10.31 Karl also did not stay home

from daycare. Exhibit 22 at 1-2; see also Tr. 565:21-22 (Dr. Snodgrass’s

testimony that one reason that he thinks the vaccinations did not significantly

aggravate Karl’s condition was the lack of evidence showing “significant

regression, being sick, calling the doctors, staying home from day care, et cetera”).

Concisely stated, Dr. Snodgrass’s opinion is that “Karl was not seriously ill in

January.” Tr. 558:8.

On January 31, 2005, Karl’s daycare provider reported that Karl was acting

“very tired fussy.” It also says “He has spots all over his arms & legs again.”

Exhibit 22 at 2. Dr. Snodgrass stated that “I think that [report of more spots] is

more of the erythema multiforme. . . . And that could be associated with fever and

irritability.” Tr. 339:20-25. In the rebuttal phase of the hearing, Dr. Snodgrass

testified that “the simplest explanation” for the January 31, 2005 incidence of red

spots “is that the erythema multiforme waxes and wanes and that was a period

when it was more evident.” Tr. 804:9-11.32

There are additional reports from the daycare provider for each day between

February 1, 2005, and February 4, 2005, inclusive. For two days, Karl was

reported as being “tired.” On an intervening day, Karl “did very good today.”

Exhibit 22 at 2.

On February 7, 2005, the daycare notes state that Karl went to a

chiropractor, and the details of this appointment are provided below. On February

8, 2005, the daycare record says: “Karl not very content not sleeping very long 1/2

[hour] at a time[,] tries to crawl pulling his body.” Exhibit 22 at 2.33

31

In the history of present illness section of Dr. McDonough’s form, the

note says “Recheck rash – better [with] Desonide.” Dr. McDonough’s assessment

includes “recurrent erthythema multiforme.” Exhibit 5 at 62.

32

Dr. Frye also viewed the presence of red spots as an indication that Karl’s

erythema multiforme had recurred. Dr. Frye connected the erythema multiforme

with an activation of Karl’s immune system that was, in turn, caused by the

vaccinations. Tr. 645:2-14.

33

This is the final daily entry from the daycare record. See footnote 28,

above.

37

2. Chiropractic Records

On February 7, 2005, Ms. Paluck brought Karl to his first appointment at the

Pokorny Chiropractic Clinic.34 The “present complaint” was that Karl was “Not

crawling / walking.” On the intake form in the blank associated with the typed text

“pain described,” there is handwriting saying that “ear infections – w/ red spots on

extrem[ities].” Exhibit 12 at 1.35 (This handwriting is probably the handwriting of

a person from the chiropractic clinic.) Another part of the intake form has different

handwriting, which is probably from Karl’s mother, saying that the reason for

Karl’s visit was “infant – not crawling, walking, problems sitting – sometimes.”

Id. at 2.

On another form, which the chiropractor used to record the treatment

provided at each visit, there is a series of boxes adjacent to the letter “O,” which

presumably stands for “objective.” The boxes are labeled Progress, NCM, Palp,

MP, Antalgia, Spasm, Edema, Pain/Tender, ROM C/S, ROM L/S. Some boxes

contain handwritten dashes, letters, or arrows, pointing either upward or

downward. The significance of these entries is not clear. Neither Dr. Frye nor Dr.

Snodgrass discussed these boxes in their testimony. Similarly, neither the Palucks

nor the Secretary referred to these boxes in their recitation of Karl’s medical

history in the briefs filed after the hearing.

34

Although Dr. McDonough had referred Karl for physical therapy and

occupational therapy following the January 19, 2005 appointment, the Palucks

were not taking Karl for therapy. One of Dr. McDonough’s later records explains

that the Palucks thought that Karl’s problem was a “pinched nerve which is

interfering with his development.” Exhibit 3 at 7.

35

When the Secretary’s counsel asked Dr. Snodgrass about whether this

report of pain meant that Karl had otitis media, the Palucks’ attorney objected due

to lack of foundation. Dr. Snodgrass agreed with the Palucks’ attorney, saying that

chiropractors “would not try to decide whether a person has an ear infection or

not.” Tr. 341:13-14.

On the other hand, Dr. Snodgrass testified—without any objection—that a

chiropractor could report the presence of a rash accurately. Tr. 340:9, 341:7-8.

38

For Karl’s first visit, the chiropractor’s notes, which are difficult to decipher,

has in the “comment section,” the following:

Dr. [Steven] McDonough / Bismarck / MedCenter 1 Clinic

X Pt. tenderness sub occip (R) ↓ ROM / head / Pot

Exhibit 12 at 4. The chiropractor’s assessment was “C-Seg. Dys.” Id. at 5.36

Two days later, Karl returned. He was described as “irritable.” There is also

a notation, perhaps preceded by an asterisk, saying “Pt hip [after] cross crawl.”

Id.37 After two more days (February 11, 2005), he was described as “spastic.” Id.

In his rebuttal testimony,38 Dr. Frye saw “irritable” as a presentation that was

“somewhat unlike Karl because he’s been described as being a very happy child

until the January 19th.” Tr. 647:1-3. Dr. Frye then discussed why the report of

spasticity was “interesting” to him. He saw “spasticity” as marking a significant

change in Karl’s status:

[A]s I mentioned before[,] changes in tone sometimes are very subtle

things. Spasticity though suggests a very severe neurological event,

. . . and [for] spasticity to actually develop within the time frame that

we see, within a month, suggests that there was very rapid change in

his central nervous system. So whereas tone is something that you

feel as far as the resistance to passive flexion, spasticity actually

suggests that there’s actually significant damage where the muscles

36

Neither party asked Dr. Frye or Dr. Snodgrass to interpret this note. It

might mean that the chiropractor assessed Karl as having a dysfunction in the

cervical segment of his spine.

37

With reference to this visit, Dr. Frye said that the chiropractor “makes a

note of some abnormalities of his of [sic] bilateral hips with cross crawl.” Tr.

647:4-5.

38

Dr. Frye did not mention Karl’s visits to the chiropractor in his reports of

March 30, 2009 (exhibit 16), July 17, 2009 (exhibit 21), or January 11, 2011

(exhibit 40). Dr. Frye also did not discuss the chiropractor’s records in his

testimony during the first day of hearing. See Tr. 32-242. Similarly, when the

Palucks prepared a demonstrative exhibit presenting a “Time Line” for Karl, the

Palucks did not include any entries from the chiropractor. See exhibit 24.

39

are being contracted forcefully because they have actually lost control

from the brain.

Tr. 647:12-23. Dr. Frye stated that in his review of Karl’s records prior to

February 11, 2005, he did not discover any caregiver noting spasticity during an

examination. In Dr. Frye’s view,

this suggests that there is significant damage to the brain, what we call

an upper motor neuron lesion, and that the neurons in the motor cortex

are severely damaged and are no longer controlling the neurons in the

spinal cord. And within that time period to go from maybe some

increased tone to becoming spastic suggests a very quick and fast

regression.

Tr. 648:7-14.

The next entry from the chiropractor is three days later, February 14, 2005.

Karl is reported as being in a “better mood.” Exhibit 12 at 5. Karl returned on

February 16, 2005, and the chiropractor described Karl as “less rigid – more

comfortable on all 4’s.” Id. On February 18, 2005, the notation is “less rigid –

‘happier.’” Id.

The Palucks did not elicit any testimony from Dr. Frye about the February

14, February 16, or February 18, 2005 records. See Tr. 648:20 to 649:1 (Dr. Frye’s

testimony describing visits on February 11, 2005 and March 30, 2005); see also Tr.

649:20 to 650:6 (the Palucks’ attorney drawing Dr. Frye’s attention to a visit on

March 17, 2005).

In his direct testimony, Dr. Snodgrass referred to the chiropractor’s records

as not showing a change in Karl.39 He stated that the records from the Pokorny

Chiropractic Clinic “talk about problems. In fact, they use the word spastic in

various places[.] . . . They often say spastic, stiff, et cetera. So they are reporting

on the same general phenomenon which first became evident to Dr. McDonough in

January.” Tr. 336:24 to 337:4.

39

Dr. Snodgrass’s expert reports also did not discuss Karl’s experience at

the chiropractor. See exhibits A, N, and BB.

40

Karl continued to go to the chiropractor every few days from February 20,

2005 to March 10, 2005, inclusive. The portion of the form labeled “S,” which

presumably stands for symptoms, contains different handwritten notations, of

which some are difficult to read. Entries include “stiff,” “irritable,” “less fussy” in

association with increased bowel movements, “less hypertonicity,” and “irritable”

in association with not sleeping well. Exhibit 12 at 6-7. Neither Dr. Frye nor Dr.

Snodgrass commented on these particular records.

In the middle of this period, Ms. Paluck brought Karl to the pediatrician’s

office because Karl’s mom thought he might have an “ear infection.” In addition,

Karl “has been a little bit fussy. Also has been coughing some and has had a bit of

rhinorrhea for the past couple weeks.” Karl was, at this time, “eating and drinking

fair. Making urine.” The doctor’s objective examination of Karl included that his

head, eyes, ears, nose and throat were “normocephalic and atraumatic.” The

doctor assessed Karl as having “Bronchitis with irritability. No current evidence of

otitis media.” Exhibit 3 at 63.

From this information, the doctor planned that Karl should receive

“[s]ymptomatic cares [sic].” The doctor recommended maintaining the routine

checkups with Karl’s pediatrician. Id.40

On March 17, 2005, Karl saw the chiropractor for the fourteenth time since

February 7, 2005. For “S,” the handwriting states “upper [illegible, perhaps “ext”

for extremities] skin blotches – back pain.” (This handwriting is not the same as

the previous entries.) For “A,” which presumably stands for “assessment,” the

record says “palpation of spine painfull [sic] Baby cries loud when touched.” Dr.

Frye commented that the report of back pain and loud crying when touched “is

suggesting that [Karl’s] starting to have spasticity of some of the axial musculature

and back pain, which would again suggest that he has some abnormal control of

those muscles.” Tr. 650:1-4. In Dr. Frye’s view, “this is something that is

progressive because we know previously he was a very happy child without any

pain.” Tr. 650:4-6.

The sequence of visits to the Pokorny Chiropractic Clinic is interrupted by a

development at Dr. McDonough’s office.

40

In his initial testimony, Dr. Frye described this visit but did not add any

additional meaningful information. See Tr. 105:9-106:4.

41

3. Social Services’ Involvement and Dr. McDonough’s

Referral to Dr. Kriengkrairut

On March 22, 2005, Ms. Paluck returned a call from Dr. McDonough. This

led to a joint phone call among Dr. McDonough, Karl’s mom, and Karl’s dad. Dr.

McDonough records the following information:

Some brief crawling

Not sitting on his own

Leans to one side

Babbling more

Rash – comes + goes

[Illegible] testing CT scan

Exhibit 5 at 72. Dr. McDonough’s plan is to refer Karl to a neurologist.

The Palucks’ attorney drew Dr. Frye’s attention to this record. Their

attorney stated:

Q: . . . That’s the first indication that we have that the

pediatrician is now concerned such to a level that Karl needs to see a

neurologist.

A: That’s true. And it looks like something about testing with a

CT scan.

***

A: . . . [Dr. McDonough] believes that some medical testing

needs to be done[.]

Tr. 107:4-13.41

On March 23, 2005, Brenda Erie from Stark County Social Services called

Dr. McDonough. The message was “Please call ASAP. Emerg[e]nt.” While the

reason for the call is “emerg[e]nt,” the details that prompted the call were not

41

Much later in Dr. Frye’s testimony, he stated “[i]f you look through the

record, . . .the pediatrician’s record, . . . after the vaccine there is no mention of

him making any babbling sounds.” Tr. 702:9-12. Dr. Frye was not asked about

the March 22, 2005 phone call.

42

provided. Dr. McDonough returned this call approximately two hours later. His

note states “Discussed peds neuro evaluation.” Exhibit 5 at 73.

Dr. McDonough completed a “Consultation Request Summary” on March

24, 2005. Dr. McDonough stated, “I have been contacted by a chiropractor in

Dickinson who is providing care for Karl. I also received contact by Stark County

Social Services regarding Karl’s lack of participation in physical and occupational

therapy.” Exhibit 3 at 7. (Dr. McDonough’s referral does not explain how the

Stark County Social Services learned that Karl was not attending therapy, as Dr.

McDonough had recommended.) Dr. McDonough said that he has “talked to the

parents and recommended a CT scan and medical evaluation for congenital

infection and inborn areas of metabolism.” Karl’s parents, however, were

“reluctant to do any medical evaluation” due to their belief that Karl’s

developmental problems were caused by a pinched nerve. Dr. McDonough

requested that Dr. Siriwan Kriengkrairut, a neurologist, conduct an “evaluation and

medical investigation[] into the etiology of his developmental delay and

hypertonicity.” Id.

Karl returned to his regular chiropractor on March 27, 2005. For the

symptoms, Karl is reported to have “Rigid lower extrem[ities]. . . . ‘Doing well ‘til

yesterday.’” The assessment is “same” and also says “‘took a few crawl steps.’”

Exhibit 12 at 7.

Although the March 27, 2005 chiropractor’s treatment record does not

explain precisely how Karl changed after “doing well” until March 26, 2005, some

additional information may be found for a visit on March 28, 2005. On that day,

Ms. Paluck brought Karl to his pediatrician’s office in Dickinson.42 Dr. Gary

Peterson, not Dr. McDonough, saw Karl for this appointment.

Ms. Paluck reported that Karl had “four days of wheezy cough, runny nose

for two weeks.” Ms. Paluck also informed Dr. Peterson that Karl had been

“[f]ussy, not eating well,” although no duration was specifically noted. Karl was

reported not to be having any ear pain, diarrhea, or nausea. Exhibit 3 at 64.

42

Ms. Paluck originally called the clinic in Bismarck, but a nurse directed

Ms. Paluck to make an appointment at Dickinson. Exhibit 5 at 74.

43

Dr. Peterson examined Karl, focusing on Karl’s breathing. There is no

mention of developmental milestones, such as crawling, speaking, or walking. Dr.

Peterson diagnosed Karl as having “1. Early bilateral otitis media. 2. Bronchiolitis,

suspect RSV.” Id. Dr. Peterson treated Karl with SVN (small volume nebulizer)

and prescribed an SVN for use at home. He did not prescribe any antibiotics,

noting that “Mother has preferred no antibiotics be written as yet since he has had

the trouble with erythema multiforme in the past.” Dr. Peterson’s note states

“Recheck tomorrow morning to ascertain improvement. See sooner for shortness

of breath.” Id.

There is no information in the record indicating that the Palucks brought

Karl in for medical treatment in the immediate days following his March 28, 2005

appointment with Dr. Peterson. The next visit was with the Pokorny Chiropractic

Clinic on April 2, 2005. See exhibit 24 (Pet’r Timeline) at 3; exhibit H (Resp’t

Summary of Medical Records) at 10.

However, before Karl returned to the chiropractor, the chiropractor

memorialized a “Phone convers[ation]” with a person whose name is difficult to

decipher but was affiliated with “SCSS.”43 The caller was inquiring about a

possible adverse vaccine reaction to which the chiropractor responded “No.” The

chiropractor also discussed “CP, cerebellar tumor.” The people also discussed

“P.T. / O.T. in conjun[ction] [with] chiro[practic] care.” Exhibit 12 at 7.

In connection with this report, Dr. Frye testified that the chiropractor “also

discusses . . . a possible adverse reaction to the vaccine.” Tr. 649:16-17. Dr. Frye,

however, failed to note that the chiropractor’s opinion was that Karl did not have

an adverse reaction to the vaccine. See id.; see also exhibit 12 at 7.

Dr. Frye interpreted “CP” as meaning cerebral palsy. To Dr. Frye, the

reference to cerebral palsy was significant because “those children with cerebral

palsy do have spasticity, but for here this is pretty significant that he has cerebral

palsy which probably affects, which affects the limbs and the motor system to a

significant extent, he actually puts in here that maybe he has a cerebellar tumor,

suggesting that he has some ataxia or some inability to control his movements very

well.” Tr. 649:4-11.

43

Given the information in Dr. McDonough’s request for a consultation,

SCSS probably refers to “Stark County Social Services” and the caller was

probably Brenda Erie. See exhibit 5 at 73.

44

Dr. Frye continued his interpretation of the chiropractor’s memorialization

of a phone conversation. Dr. Frye stated that “this is more of what we would think

of as a fine motor problem than a gross motor problem. So it seemed like he was

suggesting that there was actually something more and progressive.” Tr. 649:12-

15. Unfortunately, Dr. Frye did not define what symptom evidenced a fine motor

problem. Dr. Snodgrass did not respond to Dr. Frye’s interpretation of the

chiropractor’s March 30, 2005 phone call.

On March 30, 2005, Ms. Erie from Stark County Social Services left another

message with Dr. McDonough. Dr. McDonough’s notes from the ensuing

conversation recorded that “Mom told Pt that Baby is lazy + will await appt. Told

her that appt has been scheduled in April with Dr. Siriwan.” Exhibit 5 at 75.

Karl next saw the chiropractor on April 2, 2005. The chiropractor records

the following: “Nebulizer this [illegible, perhaps week]. Up on all 4’s longer –

seeing improvement. Less rigid – ‘good mood this week’ – taking a few crawling

steps.” On the line for assessment, the chiropractor has written in parenthesis “No

red spots for 2 wks.” On the same line, the chiropractor has also written “*‘Doing

well OT/PT since Nov.’ ‘1-2x/wk.’”44 Exhibit 12 at 7. The chiropractor’s use of

quotation marks suggests that Ms. Paluck provided the information about Karl’s

history of occupational therapy and physical therapy. However, the Palucks have

not submitted any records documenting Karl’s participation in occupational

therapy or physical therapy.

Ms. Paluck brought Karl back to the Dickinson pediatric clinic on April 4,

2005, where they again saw Dr. Peterson. The reason for the visit was Karl’s ears

were draining. The doctor’s examination focused again on respiration. The doctor

mentioned that Karl was not having a rash. Dr. Peterson diagnosed Karl as having

“Bilateral otitis media, draining on the right.” He also said that Karl’s bronchiolitis

was improving. Exhibit 3 at 66.

Dr. Peterson recommended weaning Karl from the nebulizer, and prescribed

Augmentin. Dr. Peterson also instructed Ms. Paluck to watch for rashes, hives, or

erythema multiforme. Id.

44

As noted in the text, these words appear on the line for assessment.

However, they may appear there only because there was no more room on the line

for “symptoms.”

45

On April 8, 2005, Karl saw the chiropractor again. The chiropractor

reported Karl’s “cold symptoms better.” There is an “X” inside a circle followed

by “Antibiotic / 1 wk. Augmentin.” There is another circled X followed by

“Discussed file with parents. ‘You make decisions re: Karl’s care.’ ‘Not

concerned.’” Exhibit 12 at 7.

On April 11, 2005, Mr. Paluck telephoned Dr. McDonough’s office. Mr.

Paluck reported that “Karl is crawling about 2 wks ago.” Mr. Paluck also wanted

Karl’s “ears checked.” The nurse advised Mr. Paluck “to keep appt they have

scheduled.” Mr. Paluck agreed. Exhibit 5 at 76.

The Secretary’s counsel discussed this notation with Dr. Snodgrass. The

discussion was as follows:

Q: And is it significant against your opinion of vaccine

causation that Karl was crawling about two weeks ago as of April

2005?

A: It supports my view that Karl’s problems were fluctuating.

He had times when his symptoms were worse, he had times when he

was improving. And on April 11th he was apparently doing better.

Tr. 794:10-16.

Due to Dr. Snodgrass’s reliance on Mr. Paluck’s statement that his son was

crawling, the undersigned asked Dr. Frye his views:

Q: So here there’s a telephone conversation record, Mr. Paluck

is calling and he says that Karl is crawling about two weeks ago.

How does Karl’s crawling fit within your theory of the case?

A: I think that, you know, he has – well, you know, sometimes

kiddos that have increased tone may find it easier to crawl because if

you have normal tone you actually have to push off with your

muscles. If you have actually stiff legs sometimes it’s sometimes

easier to actually crawl. So I don’t know that it necessarily negates

the fact that he had these neurologic abnormalities. And to tell you

the truth this is about the same time that we know that he had

spasticity. So I would say that he’s actually just trying to learn to

crawl despite his spasticity.

Q: Would crawling be evidence of a new achievement I guess?

46

A: I think it’s hard to say because we know that neurologically

he’s so abnormal at this point, I don’t know that we could really

interpret it within the same context of normal development.

Tr. 826:18 to 827:15.

4. Dr. McDonough – April 13, 2005

The appointment to which the nurse referred took place two days later, on

April 13, 2005. It was with Dr. McDonough. The purpose was to evaluate Karl

before he received anesthesia as part of an MRI.45 Because Dr. Frye and Dr.

Snodgrass discuss this report extensively, much of Dr. McDonough’s report is set

forth below.

Dr. McDonough’s report begins with a history of Karl’s present illness. Dr.

McDonough’s summary is consistent with the preceding recitation of facts,

although Dr. McDonough does not have details about Karl’s status as recorded by

the chiropractor. Dr. McDonough states:

Karl is a 14-month-old with global developmental delay who comes

back in for a recheck. I have had numerous phone conversations with

parents and have been trying to arrange evaluation for the global

developmental delay and erythema multiforme. The parents have

been reluctant to do this and are hesitant about any radiation exposure.

They have not been taking him in to PT as requested but have been

utilizing chiropractic services.

The parents have agreed to have him seen by Dr. Siriwan

Kriengkrairut and I have also had several conversations with the

Badlands Human Services regarding questions that they have had

regarding his evaluation.

Exhibit 3 at 9. The next pertinent portion of Dr. McDonough’s report is his review

of systems. Again, this historical overview is consistent. Dr. McDonough writes:

45

This MRI was probably scheduled in conjunction with Dr. McDonough’s

discussions with Karl’s parents at the end of March 2005. The message from one

call refers to the need for a consultation with a neurologist and a CT scan. Exhibit

5 at 72.

47

Positive for wheezing episode in March with otitis media. He has had

chronic erythema muliforme but he has not had any lesions in the past

three weeks. He has had global developmental delay and he has had

increased irritability since he has been sick frequently this winter with

ear infections. Previously, he was a very happy, laid-back child.

Id.

Dr. McDonough next describes Karl’s developmental history. Dr.

McDonough states: “Reveals that he does not sit yet. He moves a little bit more

on four-point. He is not being followed by PT or OT as requested, but is seeing a

chiropractor.” Id.

Dr. McDonough then reports about his examination of various aspects of

Karl. Pertinent parts include:

GENERAL: Karl is a vigorous, active 14-month-old with

global developmental delay. He cries when he lays on his back but is

smiley and happy and playing when he is sitting on his mom’s lap.

HIPS: His hips are tight with decreased hip flexion to about 70

degrees bilaterally with increased [sic, a word is probably missing] in

the lower extremities. This is a change on hip movement over the last

couple of months. I did call Dr. Siriwan Kriengkrairut. Did

encourage x-rays to be done of his hips but mom is reluctant to have

this done.

***

SKIN: He has a bruise on his upper forehead and a couple of

tiny bruises in his lower back. The bruise is from falling forward and

hitting his head, according to mom.

NEUROLOGIC: Examination reveals increased [sic, a word,

perhaps “tone,” is probably missing]46 in the upper and lower

extremities. Deep tendon reflexes are present. I do not sense any

clonus. Pupils equal, round, and reactive to light.

Exhibit 3 at 10. Based upon this information, Dr. McDonough assessed Karl as

having “Global developmental delay with resolving otitis media.”

46

The Palucks’ attorney suggested that the missing word was “tone.” Tr.

108:23-25.

48

Setting aside concerns about an ear infection, Dr. McDonough set forth the

following plan:

The plan is to follow up with Dr. Siriwan Kriengkrairut next week.

Dad did call and agree to an MRI and an MRI has been ordered on

4/26/2005 at 7:00 a.m. Hopefully, the parents will agree to evaluation

for congenital infections, metabolic disorders, and other tests

requested by Dr. Siriwan for his global developmental delay. He is

not speaking at this point and has obvious speech and fine and gross

motor developmental problems with some apparent hypertonicity.

Id.

As alluded to earlier in this decision, Dr. Frye and Dr. Snodgrass testified

about Dr. McDonough’s April 13, 2005 report extensively, much more than either

doctor testified about the chiropractor’s records. In his initial testimony, Dr. Frye

stated that Karl has deteriorated. Dr. Frye testified:

A: So now his [Dr. McDonough’s] examination has

significantly changed, because now he has increased tone in the upper

and lower extremities, so – and he says, ‘Global developmental delay

with resolving otitis media.’ So here his concerns are that his

neurological exam has gotten worse.

Q: And that’s worse from the examination that had been done,

both in January of 2005 and December of 2004.

A: Yes. Exactly.

Tr. 108:15-22.

When Dr. Snodgrass testified, he disagreed with Dr. Frye’s view that Karl

had gotten worse. In reference to the passage just quoted, Dr. Snodgrass said: “I

think he’s missed the point that Karl was abnormal in the fall and by January he

was showing new findings of increased tone. And that that was an important

marker, something significant had changed.” Tr. 338:5-9.

In the rebuttal phase, Dr. Frye responded to Dr. Snodgrass’s opinion. The

discussion between the Palucks’ attorney and Dr. Frye in reference to Dr.

McDonough’s April 13, 2005 examination was:

49

Q: And would that be important for us in understanding what he

finds in April versus what he found in January?

A: Well [in] January again he had this isolated gross motor

delay and maybe a little bit of increased tone. Here he is described as

having global developmental delay. And again if you have delays in

just one area you have an isolated delay and it’s not called global

developmental delay. Global developmental delay is when you’re

affected in several areas. And so now he’s describing a very different

child who has global developmental delay, that is he has now delays

in many different areas. And, you know, of course it probably isn’t as

accurate as what he should have said would be regression in certain

areas, because he previously was not delayed in these other areas.

Q: Would you take us through the physical examination that Dr.

McDonough made on April 13th, 2005?

A: Sure. Also I wanted to mention that he has a very

interesting statement here as he’s talking about Karl as having

increased irritability since throughout the winter. And of course as we

had seen in previous exams Karl was not an irritable child, he was a

very happy child. Then when we actually look at the exam it says that

he has decreased hip flexion, something he had not mentions [sic]

previously, and that hip flexion is decreased suggesting that again he

has spasticity, not just increased tone but spasticity, limitations in his

range of motion, which is what the chiropractor had mentioned back

in I believe it was February, February 11th. So this is very different

than, you know, just a difference in tone. And now he’s seeing this

because this is the first time he’s seen Karl since the previous

examination.

Q: And the examination that Dr. McDonough is doing on the

13th is a pre-MRI examination, is it not?

A: It is, yes it is.

Q: And so what else did Dr. McDonough find on April 13th?

A: So he also showed, let me just look at this. So it’s

interesting he’s seeing bruises because now Karl is falling and hitting

his head, so it suggests that he’s lost actually coordination.

Q: The neurological exam?

A: He has increased tone in his upper, now his upper and his

lower extremities. And he also mentions that he is not speaking at this

point. So on the 19th he was actually saying mama and dada, but now

he’s not speaking at all. And he has obvious speech, fine, and gross

motor developmental problems. So before, where the Denver had

50

actually showed us that he was normal in fine motor and language,

now we’re seeing that he has multiple developmental problems and he

has lost all of his speech.

Q: Would these findings on April 13th, 2005, suggest

regression in Karl’s development?

A: Most definitely.

Tr. 651:9 to 653:18.47

In one portion of this passage (Tr. 652:12-14), Dr. Frye states that Dr.

McDonough’s report of “decreased hip flexion” means that Karl had spasticity.

Dr. Frye explained that “decreased hip flexion” is “just another term for

spasticity.” He continued:

So that means there’s a limited range of motion. So spasticity causes

a limited range of motion. So he is also, he’s talking about the exact

area where there’s limited range of motion because of the spasticity.

47

In this passage, Dr. Frye made several assertions that are not entirely

accurate. For example, he testified that in January, Karl had “maybe a little bit of

increased tone.” Tr. 651:13-14. However, in January, Dr. McDonough indicated

that Karl’s neuromuscular system was abnormal and Karl had increased muscle

tone in his upper and lower extremities. Exhibit 3 at 3 (progress note), exhibit 5 at

35 (Denver screening form).

Next, Dr. Frye mentioned Karl’s irritability. Tr. 652:6. But, the full context

of Dr. McDonough’s report is that Karl has “had increased irritability since he has

been sick frequently this winter with ear infections.” Exhibit 3 at 9. This

irritability is consistent with Karl’s pre-vaccination history in which he was

reported to be fussy in the context illnesses. See id. at 52, 58, 60. Dr. McDonough

also reported that Karl is “smiley and happy and playing when sitting on his

Mom’s lap.” Id. at 10.

In addition, Dr. Frye testified that on January 19, 2005, Karl “was actually

saying mama and dada.” Tr. 653:9. Actually, Karl’s ability to say words on

January 19, 2005 was more ambiguous. Although the Denver screening form

contains a “pass” for “dada-mama specific,” exhibit 5 at 35, Dr. McDonough’s

own form does not include a positive notation for this skill. See exhibit 3 at 3. In

any event, even if Karl could say “mama” and “dada” on January 19, 2005, this

limited ability is still a decline in his language abilities from December 27, 2004,

when Karl “ha[d] several words that he says.” Exhibit 3 at 5.

51

You see he says the hips are tight, so tight is another word for

spasticity, meaning the muscles are so tight they’re bringing the hips,

they’re limiting the hips’ ability to move in their normal range.

Tr. 727:23 to 728:7; contra, Tr. 824:22 to 825:8 (Dr. Frye stating that he does not

think that Karl had spasticity on January 19, 2005).

After hearing Dr. Frye’s testimony, Dr. Snodgrass was asked to explain

whether the vaccines changed the course of Karl’s disorder. Dr. Snodgrass stated

that he saw “no evidence that the vaccines changed the course of [Karl’s]

disorder.” Tr. 793:5-6. Dr. Snodgrass stated (again) that he thought that Karl’s

clinical course fluctuated before and after the vaccine. In this context, Dr.

Snodgrass stated, “I think the amount of hip flexor abnormality that was present

was probably greater in April than in January, but there was no ankle clonus. So in

other words we have certain areas where he looked a bit worse than he did in

January and others where he did not.” Tr. 793:14-19. Dr. Snodgrass also

discusses here Karl’s visit to the neurologist, Dr. Kriengkrairut.

5. Dr. Kriengkrairut on April 19, 2005

Dr. Kriengkrairut saw Karl on April 19, 2005 because Dr. McDonough had

referred Karl “due to delayed development, not sitting up yet, unable to keep

balance when he is sitting up.” Exhibit 3 at 83. Like Dr. McDonough’s April 13,

2005 report, Dr. Kriengkrairut’s report is quoted here in detail because the experts

rely upon this report so heavily.

Dr. Kriengkrairut’s recitation of Karl’s history begins with his birth. In

pertinent part, Dr. Kriengkrairut recounts the following information beginning with

the onset of the erythema multiforme:

Mother felt that he did well in the first 6 months, then he did have

some problem with serious skin lesion. This was approximately in

October 2004. According to the father, his whole body swelled up.

. . . It was diagnosed as erythema multiforme, suspected secondary to

medication hypersensitivity reaction, exact allergy was unknown.

This was also secondary to viral infection. According to the father

since then, the child has regressed.

Exhibit 3 at 83. The parents’ narrative (as written by Dr. Kriengkrairut) explains

what happened to Karl before he was vaccinated:

52

In December of 2004, his condition got worse. His hands and feet

were swelled up. He was given medications.

Id. At this point, it appears that Dr. Kriengkrairut is presenting information about

more recent history.

This [sic, a missing phrase might be “skin condition”] has markedly

improved from a month ago when he seemed to be back to normal.

Father reported that since he has been improving with the skin lesion,

he also has made progress in terms of development, but overall he is

still behind. Parents reported that he has tendency to do fisting of

both hands, even when he holds a bottle he will keep his hand

clenched up. Recently, he seemed to open his left hand more.

Id. Then, Dr. Kriengkrairut describes various attempted interventions.

Mother has tried chiropractic treatment in him. She was told that the

child had some stiffening of the extremities secondary to a nerve

pinch in his back. Dr. McDonough has ordered physical and

occupational therapy in Dickinson; however, parents have not made

the appointment yet. Parents are very reluctant for any therapy

treatment. Mother felt that the child is unable to sit up due to unable

[sic] to balance secondary to curvature of his back. Recently he was

able to crawl 2-3 crawling movements at the time.

He has not made any specific words. He has been sick quite

often. This includes frequent ear infections.

Id.

Dr. Kriengkrairut’s review of systems is relatively brief, repeating some of

what was just stated. For skin, Dr. Kriengkrairut reports Karl’s past history of

erythema multiforme and says that “[i]n the last one month, seems to be doing

much improved.” Exhibit 3 at 84. For neurologic, Dr. Kriengkrairut states “[t]he

parents were told that he has stiffening of both legs and also delay.” Id.

As part of the physical examination, Dr. Kriengkrairut conducted a motor

examination. This “revealed truncal hypotonia with marked spasticity of the

extremities. The baby has tendency to do cortical thumb bilaterally, worse on the

right compared to the left.” Id.

53

Dr. Kriengkrairut also used the Denver screening test. Dr. Kriengkrairut

recorded: “The patient unable to sit alone, does have good eye contact, able to

follow in all directions. The baby does not babble. Parachute reflex is not

detected.” Id.

Dr. Kriengkrairut reached three impressions about Karl: “1. Global delayed

development. 2. Truncal hypotonia with hypotonicity of the extremities. 3.

Etiology to be determined.” Id. She also recommended various things to the

Palucks, including that Karl would benefit from physical and occupational therapy.

Since Dr. Kriengkrairut’s evaluation was the first time Karl saw a

neurologist, Dr. Frye and Dr. Snodgrass discussed her assessment extensively. In

Dr. Frye’s direct testimony, he mentioned the following problems that Dr.

Kriengkrairut reported as significant: Karl’s irritability, fisting, truncal hypotonia,48

spasticity in his extremities, and bilateral cortical thumbing.49 Tr. 110:2 to 112:9.

Karl’s lack of babbling, as reported by Dr. Kriengkrairut, was especially important

to Dr. Frye because Karl was babbling before his January vaccinations. See

exhibit 3 at 3. The decrease in babbling is “suggesting that now he’s losing

cognition and language . . . . It’s suggestive of neurodegeneration or regression in

development, which is caused by mitochondrial disorder.” Tr. 112:24 to 113:7.

Dr. Snodgrass disagreed, at least in part. Dr. Snodgrass viewed other

abilities, such as Karl’s ability to roll over, as consistent between Dr.

McDonough’s January 19, 2005 evaluation and Dr. Kriengkrairut’s April 19, 2005

assessment. See Tr. 358:13-25. For Dr. Snodgrass, “Dr. Siriwan is not finding

that Karl has lost a skill which Dr. McDonough had previously recorded as

present.” Tr. 359:4-6.

On the other hand, when Dr. Snodgrass was asked to comment upon Dr.

Frye’s testimony that Karl worsened between January 2005 and July 2005, Dr.

Snodgrass stated Karl “got worse in April/May.” Tr. 367:16-17. Unfortunately,

48

In truncal hypotonia, “the axial musculature cannot support [the person] to

actually sit up in any way or probably even stand.” Tr. 654:14-16 (Dr. Frye).

49

Cortical thumbing occurs when the thumb is inside a closed hand. It is

normal in newborn children but abnormal by age one. Tr. 582:25 to 583:14 (Dr.

Snodgrass), 705:1-9 (Dr. Frye).

54

Dr. Snodgrass was not asked to identify the features in Karl that made him

conclude that Karl was worse in April or May than in January.

Near the end of the Palucks’ cross-examination of Dr. Snodgrass, their

attorney asked him about two of the features identified by Dr. Kriengkrairut that

Dr. Frye saw as “new” findings. First, there was a question about cortical

thumbing that Dr. McDonough had not reported in January 2005. Dr. Snodgrass

stated, “I would not expect a pediatrician to notice that and that is a very minor

finding. It was not reported by Dr. McDonough, it was not reported by the

chiropractor. But I wouldn’t expect either one of them to notice that.” Tr. 577:21-

25. Counsel then challenged Dr. Snodgrass: “[A]ctually cortical thumbing is quite

a significant finding, isn’t it?” Dr. Snodgrass replied “I would disagree with you.”

Tr. 578:1-3.

The second topic was the truncal hypotonia. Again, Dr. Snodgrass did not

agree with the characterization that this problem was new in April. The exchange

between the Palucks’ attorney and Dr. Snodgrass was:

Q: Dr. S also made an objective finding in April 2005 of truncal

hypotonia, that was not present in January 2005 either, was it?

A: It was not reported by Dr. McDonough.

Q: So that’s a new finding.

A: I don’t think so. In order to determine truncal hypotonia,

you have to do things with the child which I don’t believe a

pediatrician would do. I think the issue about - -

Q: You don’t know that for a fact though, do you, Dr.

Snodgrass?

A: I don’t know it for a fact as concerning Dr. McDonough. I

deal with pediatricians and pediatric residents every day and I know

what they do.

Tr. 578:4-17.

The undersigned asked Dr. Snodgrass to elaborate on his answers regarding

truncal hypotonia and cortical thumbing. For cortical thumbing, Dr. Snodgrass

stated “[i]n the context of multiple findings of increased tone in upper and lower

extremities, the presence or absence of this finding is not significant.” Tr. 583:19-

22.

55

This dispute carried over into the rebuttal phase of the case. Dr. Frye said

cortical thumbing “is a significant sign of advanced upper motor neuron lesions

and something you don’t see with just some type of change in tone or even mild

spasticity, that is a very significant finding.” Tr. 654:22-25. The presence of

cortical thumbing means that the spasticity “now has affected the upper extremities

too and actually the thumbs.” Tr. 655:9-10.

Dr. Frye also discussed the truncal hypotonia that Dr. Kriengkrairut

detected. Dr. Frye stated that truncal hypotonia meant that Karl was not sitting.

This is a significant change from January 2005, when Dr. McDonough reported

that Karl could pull to stand. Tr. 654:11-25; see also exhibit 5 at 62 (Dr.

McDonough’s report).

Dr. Frye also repeated the point that between January 2005 and April 2005,

Karl lost language. Dr. Frye stated in January, Karl was saying “mama and dada,”

which is more complex than babbling. Tr. 656:3-10; see also exhibit 5 at 62 (Dr.

McDonough’s report). In contrast, in April, Dr. Kriengkrairut states that Karl was

not babbling. Exhibit 3 at 84. Dr. Frye concludes that Karl “has an obvious very

severe regression in language from where he was at 12 months.” Tr. 656:12-13.

When Dr. Snodgrass returned to testify again, he did not further address the

cortical thumbing or the truncal hypotonia. Dr. Snodgrass did, however, comment

upon changes in Karl’s language. Dr. Snodgrass pointed out that on March 22,

2005, Karl was reported to be “‘babbling more.’” Tr. 789 (quoting exhibit 5 at 72).

6. April 27, 2005 MRI

Following Karl’s appointment with Dr. Kriengkrairut, he saw the

chiropractor again. For symptoms, the chiropractor has recorded, among other

things, that Karl had a decreased range of motion. Exhibit 12 at 8. Neither Dr.

Frye nor Dr. Snodgrass commented upon this particular record.

On April 26, 2005, Karl entered Medcenter One Hospital for his scheduled

MRI. Upon admission, Karl was examined by Dr. McDonough. The report from

Dr. McDonough’s examination presents Karl’s history, which is consistent with

what has been described previously. In terms of developmental history, Dr.

McDonough states that Karl “rolls over but does not sit without support. He does

not crawl and does not say any words.” Exhibit 3 at 12-13. For Karl’s skin, he did

not have a rash. For Karl’s extremities, there were “no signs of ankle clonus.” For

Karl’s hips, Dr. McDonough stated, “Hips are tight on range of motion of hips. I

56

have asked mom to have Dr. Siriwan Kriengkrairut evaluate his hips, as well, to

see if we should obtain x-rays. Parents are very hesitant to do any irradiation of

Karl.” Id. at 13. Dr. McDonough recommended that Karl have the MRI as

ordered by Dr. Kriengkrairut and receive services to improve his development. Id.

When the Palucks were meeting with the anesthesiologist before the MRI,

the Palucks told that doctor that they were concerned that Karl had a possible ear

infection. The doctor requested that Dr. McDonough see Karl again. Exhibit 5 at

52.

Dr. McDonough’s notes contain a review of Karl’s systems. For this entry,

Dr. McDonough wrote that Karl had a “runny nose, cough, fussiness, irritability,

and possible otalgia.” Dr. McDonough also wrote “[w]e have been urging an

evaluation for developmental delay and the parents have been somewhat reluctant

to have this done and have agreed to have an MRI without contrast.” Exhibit 5 at

52.

Under “PLAN,” Dr. McDonough recorded his answer to Mr. Paluck’s

question about what was happening with Karl. Dr. McDonough said that he

thought Karl “had problems with development resulting from problems with his

brain function and that we could not determine the etiology of this. I told him I did

not think it was a pinched nerve as told them by the chiropractor.” As to a

recommendation, Dr. McDonough stated that he “also re-encouraged them to get

him in PT/OT. I had made this recommendation four months ago and it has yet to

be accomplished. The parents decided to take him to chiropractor instead.” Dr.

McDonough concluded the entry by stating that Karl was “somewhat croupy

afterwards but seemed to be doing well when anesthesia sent him home.” Exhibit

5 at 53.

Karl did have an MRI as planned. The results included multiple images,

including diffusion-weighted images. The doctor who interpreted the results

stated: “The corpus callosum is intact. White matter distribution appears normal

and myelination is appropriate for age.” The ultimate conclusion in April 2005,

was that it was a “Normal MRI brain scan.” Exhibit 4 at 11.50

50

When Karl was hospitalized due to more serious neurologic problems in

July 2005, this MRI was re-reviewed. Then, the MRI was interpreted as showing

apparent abnormality in his corpus callosum. Exhibit 18 at 11.

(. . . continued)

57

The day after the MRI, Karl was seen at the Dickinson Clinic by Dr.

Peterson. The chief complaint was that Karl had a croupy cough. Dr. Peterson

records the history, provided by Ms. Paluck, that Karl had an MRI yesterday and

that he needed a breathing tube. Dr. Peterson also recorded the history that Karl

had been having cold symptoms for a few days before the MRI. Karl’s parents

estimated his pain level was “8/10.” Exhibit 3 at 67.

Dr. Peterson assessed Karl as having “Croup, viral versus irritation from the

anesthesia procedure yesterday for the MRI.” Dr. Peterson recommended

continuing an antibiotic, which Dr. McDonough had prescribed, and SVN

treatment. Dr. Peterson also supported the parents’ plan to see an ENT about

having tubes placed in Karl’s ears. Exhibit 3 at 67-68.

7. Speech Therapy

In early May 2005, Karl began seeing Trisha Getz, a speech therapist.

Several of his next medical appointments were with Ms. Getz.51

At the initial evaluation, Ms. Getz recorded that the Palucks said that Karl

“had an MRI last week which has ‘wiped him out’ and they report a decrease in

many skills since undergoing the anesthesia.”52 The Palucks provided information

about Karl’s sucking, drinking, and swallowing skills. Ms. Paluck “reports

During the course of the litigation, Dr. Snodgrass reviewed the original MRI

scan. He, too, concluded the April MRI was abnormal. Tr. 371:11-13, 373:13-19;

see also Tr. 484:16-20.

When asked whether he had reviewed the original MRIs, Dr. Frye stated that

“I believe I did, although I haven’t done that recently.” Tr. 731:10-11.

51

Ms. Getz’s reports tend to be written in all capital letters. When there is a

quotation from Ms. Getz, it is restated using lowercase letters as appropriate

without any notation of this alteration.

52

In addition to this account provided approximately seven days after the

MRI, Ms. Paluck provided histories to other doctors in which she states that after

the MRI, Karl lost abilities. See, e.g. exhibit 11 at 5 (“Mom states that since the

MRI there has been a loss in abilities”).

58

decrease in speech production in the last few months. Karl was able to produce a

variety of consonants but consonant production has stopped and during today’s

evaluation only a couple vowel sounds were heard.” Exhibit 6 at 5.

When Ms. Getz tested Karl, he scored in the first and third percentile for

expressive language and auditory comprehension, respectively. In Ms. Getz’s

evaluation, she did not hear any “true words, vocal imitation, solitary vocal play or

sound combinations.” She did not observe Karl demonstrating comprehension of

spoken phrases such as “let’s go bye bye,” although Ms. Paluck reported that Karl

could understand those phrases at home. Ms. Getz recommended more speech

therapy to improve Karl’s expressive and receptive skills. Exhibit 6 at 5-6.

Dr. Frye stated that a comparison between Karl’s language ability in October

2004 (the K.I.D.S. evaluation including the Bayley and Vineland) and Karl’s

language ability as measured in May 2005 “document[] that he’s now lost

language milestones considerably.” Tr. 114:2-3; accord Tr. 657:24 to 659:6.53

With reference to a slightly later speech evaluation, Dr. Snodgrass essentially

agreed that Karl had lost language skills between October 2004 and May 2005. Tr.

471:5 to 472:8.

On May 9, 2005, Ms. Getz saw Karl again for 30 minutes of speech therapy.

On four objective measurements (approximate sounds, combine sounds, produce

consonants, and respond to commands), Karl scored a zero. Ms. Getz noted that

Karl “cried throughout most of session. He appeared uncomfortable around new

therapists and therapists today worked on building rapport with Karl.” Ms. Getz

recommended that rapport-building continue and that his parents let Karl see their

faces when they are speaking. Exhibit 6 at 36.

Also, on May 9, 2005, Karl went to the chiropractor. This visit was his only

visit in the month of May. There is very little information about this visit, no

53

In discussing Karl’s language abilities before the vaccination, Dr. Frye

states that Karl “had no problems with language . . . at 12 months of age or before

that.” Tr. 658:5-7. Actually, Karl was slightly delayed in language. See exhibit

15 at 2-3.

However, Dr. Frye’s arguably rosy characterization of Karl’s ability in

October 2004 does not change his overall point – that Karl’s ability with language

significantly deteriorated between October 2004 and May 2005. On this point, as

noted in the text, the experts agreed.

59

arrows at all. For symptom, the entry states “not much strength since MRI.”

Exhibit 12 at 8.

On May 11, 2005, Dr. McDonough wrote a letter about Karl to Dr.

Kriengkrairut. It appears that Dr. McDonough did not evaluate Karl on this date.

Rather, the letter summarizes results of various laboratory tests. The letter also

states that the “MRI showed no abnormalities.” Dr. McDonough concludes, “At

this point etiology of [Karl’s] developmental delay has not been discovered and

may not be known.” Dr. McDonough requests Dr. Kriengkrairut’s opinion as to

whether “a brain wave study would be of assistance as he does have intermittent

irritability.” Exhibit 5 at 29.

Also, on May 11, 2005, Karl had an in-person consultation with Dr. W.

Thomas Coombe, a specialist in ENT. Dr. McDonough had referred Karl because

of recurrent otitis media. Dr. Coombe scheduled Karl for a “BTT” the next day.

Exhibit 10 at 1-2. Karl did have tubes placed in both ears on May 12, 2005. Karl

was given anesthesia. Id. at 5.

The same day, Karl had another speech therapy session with Ms. Getz. Ms.

Getz recorded that she observed Karl swallowing from a bottle. Karl continued to

score zero on the four objective measurements. Ms. Getz stated that Karl had “less

fussiness throughout this therapy session.” He “did cry frequently but was able to

be calmed easier through movement.” In addition, “Karl did reach for toys and

reached for wanted items during play.” Ms. Getz also recorded that Karl

“[c]ontinues to be seen by PT and OT for gross and fine motor concerns.” Exhibit

6 at 35.

The next session with Ms. Getz was on May 13, 2005. Based upon the

previous session’s work, Ms. Getz introduced a new objective standard – “indicate

desired toy by reaching for toy.” Karl did this task four times. He also

“respond[ed] to commands” once. For two other objective tests (approximate

sounds and produce consonant commands), Karl again scored zero. Ms. Getz’s

assessment was that “Karl was calm and participated without excessive fussiness

for the first 15 minutes of therapy and then became very fussy and cried the

duration of the session.” Ms. Getz added that “Karl did appear to be able to sit

better and communicate desire for toy with improvement from previous sessions.”

Exhibit 6 at 34.

Karl saw Ms. Getz on May 17, 2005. As a subjective impression, Ms. Getz

recorded that “Dad reports he believe’s [sic] Karl’s strength is increasing.” For

60

objective tests, Karl indicated a desired toy by reaching for it eight times. He did

not approximate sounds. Ms. Getz’s assessment was that “Karl was able to

indicate his desired toy more frequently today than previous visits. Karl continues

to cry during therapy although the amount of time crying is decreasing.” She also

stated that “Karl is producing much more eye contact with therapist and laughed

while appearing to enjoy play with a ball. Karl would reach for the ball and the

sign for ‘more’ was used consistently through therapy as was the sign for ‘all

done.’” Ms. Getz also recommended some stretching exercises to help reduce

Karl’s drooling, which Mr. Paluck associated with getting new teeth. Exhibit 6 at

33.

In the morning on May 19, 2005, Karl had another appointment with Ms.

Getz. Under “subjective,” Ms. Getz stated that “Karl appeared more tired today

and mom reports he was given a decongestant which may have made him

fatigued.” Ms. Getz continued that “OT and PT noted his high tone was decreased

today and mom reports they have really been working a lot with him at home. Karl

appeared more relaxed today.” In the “objective” section, Karl had a four for

“reaching for desired toy.” He still scored zero for “approximate sounds.” Ms.

Getz also introduced various stretching exercises for his lips and cheeks. Exhibit 6

at 32.

Also on May 19, 2005, Mr. Paluck brought Karl to the Dickinson Clinic

where he saw Dr. Peterson. Mr. Paluck reported that Karl woke with green nasal

mucus and was crying and unhappy. Dr. Peterson’s record of “objective”

measurements reports normal results, including “normal muscle tone” in Karl’s

musculoskeletal system. Dr. Peterson assessed Karl as having a “[s]inus infection

and viral syndrome.” Dr. Peterson recommended medications, including over-the-

counter cold and cough medicine. Exhibit 3 at 69.

On May 20, 2005, Karl had another session of speech therapy with Ms.

Getz. He reached for a desired toy six times but still could not approximate or

produce consonants. Karl “tolerated stretches and vibration [to his mouth] with

much less reluctance than last session.” Exhibit 6 at 31. Karl performed similarly

during a May 24, 2005 session. Id. at 30.

Speech therapy continued on May 26, 2005. His objective score for

producing words or consonants was zero. Ms. Getz reported that “Karl still has not

produced any vocalizations other than crying during therapy. Dad reporting

hearing Karl say ‘mom’ at home in reference [to] his mom.” Ms. Getz’s plan for

the next session was to “attempt tongue lateralization.” Exhibit 6 at 27.

61

The next three sessions (May 27, 2005, May 31, 2005, and June 2, 2005)

were relatively similar. In the first of these three appointments, Karl did not move

his tongue to get a piece of cereal placed inside his cheek. In these sessions, Karl

did not respond as well to the stretching exercises, possibly because his mouth was

sensitive due to teething. Exhibit 6 at 24-26.

The June 2, 2005 treatment was Karl’s 12th appointment. On this date, Ms.

Getz created an “Outpatient Speech Therapy Recent Summary” for Dr.

McDonough to review. Ms. Getz recorded that Karl’s diagnosis was “global

developmental delay,” he had “good” motivation/cooperation, and his potential for

rehabilitation was “good for stated goals.” The treatment plan was for Karl to

receive therapy three times per week for four weeks. Exhibit 6 at 23.

In the next speech appointment, on June 8, 2005, Karl could not reach a

piece of cereal placed inside his cheek. Ms. Getz stretched Karl’s mouth. During

stretches, Karl cried and needed frequent calming. He reached for a desired toy

four times. Exhibit 6 at 20.

On June 10, 2005, Karl returned to the chiropractic clinic for the first time

since May 9, 2005. The notes for “symptoms” appear to read “Mid TT [illegible]

Upper CP ↓.” In the row of “objective” values, there is an upward pointing arrow

for “progress” and a downward arrow for “ROM C/S.” Exhibit 12 at 8.

On this date, Karl also had a visit for speech therapy. The progress note was

relatively short, noting how many stretches were performed with Karl. Attempts

for Karl to perform “tongue lateralization” were “not completed due to sensitivity

in mouth with teething.” Ms. Getz’s assessment was “Karl’s only verbalizations

continue to be crying. He does appear to have increasing tone with oral motor

structures. Continues to slowly progress.” Exhibit 6 at 19.

Dr. Thomas Coombe, the doctor who placed tubes in Karl’s ears, examined

Karl as part of a follow-up appointment on June 13, 2005. One of the nurses

recorded a statement from the Palucks that Karl “has had no ear infections and

sleeps fairly well[].” Dr. Coombe reported that the tubes were in good position in

the ears and expected the tubes would extrude in eight to nine months. Exhibit 10

at 21.

On June 14-15, 2005, Karl had speech therapy appointments with Ms. Getz.

On both days, he appeared to be teething and his discomfort interfered with the

62

stretching exercises. Exhibit 6 at 18. On the latter day, Ms. Getz’s assessment was

“More attentive to new toys today. Pt smiling with play with cars while sitting on

therapist[’]s lap at table. Pt also enjoyed play with blocks. No vocalizations heard

today other than crying.” Id. at 17.

Karl had consecutive appointments at the Pokorny Chiropractic Clinic on

June 16 and 19, 2005. On June 16, 2005, the chiropractor’s handwritten notes for

the subjective portion are particularly difficult to read. In the objective portion,

within the “progress” box, there are two up arrows and one down arrow. In the

“ROM C/S” box, there are two arrows, one up and one down. For June 19, 2005,

there is a report that “Baby fell during storm last night.” Another line states “Baby

crying much more Relaxed Post [accident].”54 Karl had a tender thoracic spine.

There was a downward pointing arrow in the progress box. There was no entry for

ROM/CS box. Exhibit 12 at 8.

On June 20, 2005, Karl returned for more speech therapy. Mr. Paluck

reported that he had been trying to place food in Karl’s cheeks as Ms. Getz had

recommended, to encourage tongue lateralization. Karl tolerated stretches well.

“Karl did appear to enjoy looking at books and models were provided for ‘more’

both verbal and signs. Animal sounds were also modeled for Karl to imitate

including moo and baa.” Exhibit 6 at 15.

Two more sessions were held on June 27 and 30, 2005. On both occasions,

Karl was sensitive to stimulation in his mouth. Karl also was having difficulty

protruding his tongue in both sessions. Exhibit 6 at 11-12.

On July 1, 2005, Karl went to the chiropractor. The information from this

visit is sparse. The only word in the subjective line is “irritable.” There are no

arrows, either upwards or downwards, in any of the objective boxes. This was

Karl’s final visit to the chiropractor before the onset of seizures. Exhibit 12 at 8.

Karl’s next three appointments were for speech therapy on July 5, 7 and 11,

2005. There is relatively little detail about Karl, mostly comments about how he

responded to stretching exercises. Exhibit 6 at 8-10. The July 5, 2005 entry states

54

This entry lacks a period. It is difficult to tell whether the chiropractor

meant “Baby crying much more. Relaxed Post-[accident].” or “Baby crying.

Much more relaxed Post-[accident].”

63

that Ms. Getz “attempted use of picture symbols with Karl looking at pictures but

not reaching for or touching pictures.” Id. at 10.

Ms. Getz reported on her evaluation of Karl in a progress note she wrote to

Dr. McDonough on July 6, 2005. She described Karl as “slow to progress toward

goals, continues to work toward current goals.” She recommended that Karl be

seen two times a week for four weeks. Exhibit 6 at 13.

8. Seizures and Hospitalization

On July 12, 2005, Karl was “napping and woke up and eyes rolled back into

head and became unresponsive.” Exhibit 6 at 66 (report from ambulance service);

accord exhibit 6 at 68 (report from emergency room doctor). An ambulance was

called. When the ambulance personnel arrived, Karl responded to their voices with

eye movements. Karl did not respond to physical stimuli. Later, Karl “returned

unresponsive to verbal or physical stimuli.” The ambulance brought him to the

local (Dickinson) emergency room. Exhibit 6 at 66.

At the emergency room, Karl’s mother, father and emergency medical

service personnel provided a history. According to this history, Karl did not have a

fever, ear pain, eye irritation or discharge, nasal discharge, congestion, sore throat,

cough, or difficulty breathing. He also did not have vomiting, diarrhea, bloody

stools, headache, difficulty with urination, joint pain, extremity pain or decreased

urine output. The history of present illness includes a statement that Karl “is

severely developmentally delayed.” His temperature was 100.5 initially and was

102.1 one hour later. Exhibit 6 at 68.

A doctor reviewed Karl’s systems and ordered laboratory tests. Karl also

had a lumbar puncture. The doctor prescribed at least three doses of Ativan. The

third dose came when Karl appeared to have another seizure while a doctor was

examining him. After Karl remained in the emergency department for

approximately six hours, he was transferred by ground ambulance to a hospital in

Bismarck. Exhibit 6 at 68-69; see also id. at 62-65 (discharge summary from

Dickinson).

Dr. McDonough admitted Karl to the Medcenter One Hospital in Bismarck.

Dr. McDonough described Karl as a “17-month-old . . . with status epilepticus.”

Karl “was in his normal state of health today when he developed his eye deviation,

flaccidity, hypotonicity and jerking of his right arm.” Karl “later developed a

fever.” Exhibit 5 at 55.

64

In Dr. McDonough’s past medical history, he states that Karl has “global

developmental delay.” Karl “has seen Dr. Siriwan Kriengkrairut in evaluation.”

“He was to have urine organ [sic] acid, amino acids ordered and this was several

months ago and has not been done so his initial evaluation as directed by Dr.

Kriengkrairut has not been completed yet.” Dr. McDonough also notes that Karl

“is getting physical therapy and occupational services in Dickinson.” Id.

For developmental history, Dr. McDonough wrote “he has no language. He

does do some babbling.” Karl “does roll over. He holds his head up well but has

not been able to crawl, does not pull to stand.” Id.

Dr. McDonough conducted a physical examination. He noted that “[m]uscle

tone is mild increased tone lower extremities even with the medication effect. He

has tight heel cords. There is no ankle clonus. Deep tendon reflexes are

symmetrical.” Exhibit 5 at 56.

Dr. McDonough’s plan was to order more laboratory studies, an X-ray, and

an EEG for the next day. He noted that Ms. Paluck was “anxious to get him down

to the twin cities for neurological evaluation.” Exhibit 5 at 57.

On July 13, 2005, Karl underwent an EEG. Dr. Kriengkrairut wrote the

“neurodiagnostics report,” interpreting the EEG as “abnormal.” There was

“generalized slowing of background rhythm, which may indicate cerebral

dysfunction.” Dr. Kriengkrairut recommended a follow up study noting the

medications that Karl was taking could affect the results of the EEG. Exhibit 4 at

8-9.

Karl remained in Medcenter One Hospital for five days. Dr. McDonough

presented pertinent information about his course, as well as the results of Dr.

McDonough’s examination when Karl was leaving the hospital in a discharge

summary, dated July 16, 2005. Dr. McDonough assessed Karl as having “[g]lobal

developmental delay with seizure disorder, possible deteriorating neurologic status

in that he is unable to do some things that he was able to do previously.” Dr.

McDonough stated that there was “no obvious[] etiology on MRI,” but when Dr.

McDonough made this statement the abnormalities in the April 27, 2005 MRI had

not been recognized. Dr. McDonough “suspect[ed] that he has an underlying

seizure disorder which hopefully can be controlled with [medication].” Exhibit 3

at 18.

65

The plan was for Karl to go for more advanced evaluation at another

hospital. Dr. McDonough arranged for Dr. Michael Frost at St. Paul Children’s

Hospital to see Karl and for unnamed doctors at Gillette’s Children Hospital to see

him as well. Id.

The first of these appointments took place on July 19, 2005, with Dr. Frost

of Children’s Hospital. As a prelude to the examination, an intern / medical

student obtained a history of present illness.55 In this account, Karl “began

showing evidence of motor delay at appox[imately] 11 mo[nths] of age. He was

trying to crawl and had some vocal sounds, was happy and using both hands

purposefully.”56 The history continues: “He then developed rashes. He did have

history of ear infections. His tone began increasing.”57 The history also states “By

14 mo[nths] no significant progress in development. He was seen by Dr.

Kriengkrairut neurologist in April & MRI on 4/27/05 was read as normal.” Karl’s

recent medical history continues: “Mom states that since the MRI there has been a

loss in abilities[,] increase in tone with tremors with stimulation not present in

sleep. He is extremely irritable.” The intern / medical student also recorded that

Karl “has [decreased] truncal tone with loss of some head control. He has been

receiving therapies with some intermittent [decreased] tone but overall declining in

all areas.” Exhibit 11 at 5.

At this point, the history recounts Karl’s immediate medical history, starting

with the event on July 12, 2005. “[W]hile with baby sitter [Karl] woke up from

nap[,] eyes rolled back & stiffened. Paramedics called. [Karl was] unresponsive

on arrival & continued to seize.” The history lists the medication and treatmen

This text is long and has been trimmed here. Open the source document for the complete record.