BROWN, et al v. AMERICAN HOME PROD, et al

Filing 4901

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9149 RE: CLAIMANT TOM S. YEARY. SIGNED BY HONORABLE HARVEY BARTLE, III ON 9/25/2013; 9/25/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110119 IN 11-MD-1203). (tjd)

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: DIET DRUGS (PHENTERMINE/
FENFLURAMINE/DEXFENFLURAMINE)
PRODUCTS LIABILITY LITIGATION

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MDL NO. 1203

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THIS DOCUMENT RELATES TO:

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SHEILA BROWN, et al.

v.
AMERICAN HOME PRODUCTS
CORPORATION

CIVIL ACTION NO. 99-20593
2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

September cl,S";' 2013

Bartle, J.

TomS. Yeary ("Mr. Yeary" or "claimant"), a class
member under the Diet Drug Nationwide Class Action Settlement
Agreement ("Settlement Agreement") with Wyeth,
from the AHP Settlement Trust ("Trust").

1

seeks benefits

Based on the record

developed in the show cause process, we must determine whether
claimant has demonstrated a reasonable medical basis to support
his claim for Matrix Compensation Benefits ("Matrix Benefits")
and, if so, whether he met his burden of proving that his claim
was not based, in whole or in part, on any intentional material
misrepresentation of fact.

2

1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
In 2009, Pfizer, Inc. acquired Wyeth.
2.

Matrix Benefits are paid according to two benefit matrices
(continued ... )

To seek Matrix Benefits, a claimant must first submit a
completed Green Form to the Trust.
three parts.

The Green Form consists of

The claimant or the claimant's representative

completes Part I of the Green Form.

Part II is completed by the

claimant's attesting physician, who must answer a series of
questions concerning the claimant's medical condition that
correlate to the Matrix criteria set forth in the Settlement
Agreement.

Finally, claimant's attorney completes Part III if

claimant is represented.
In October, 2002, claimant submitted a completed Green
Form to the Trust signed by his attesting physician, Dominic M.
Pedulla, M.D., F.A.C.C.
litigation.

Dr. Pedulla is no stranger to this

According to the Trust, he has signed in excess of

128 Green Forms on behalf of claimants seeking Matrix Benefits.
Based on an echocardiogram dated August 7, 2002, Dr. Pedulla
attested in Part II of claimant's Green Form that Mr. Yeary

2.
( ... continued)
(Matrix "A" and Matrix "B"), which generally classify claimants
for compensation purposes based upon the severity of their
medical conditions, their ages when they are diagnosed, and the
presence of other medical conditions that also may have caused or
contributed to a claimant's valvular heart disease ("VHD").
See
Settlement Agreement§§ IV.B.2.b. & IV.B.2.d. (1)-(2). Matrix A-1
describes the compensation available to Diet Drug Recipients with
serious VHD who took the drugs for 61 days or longer and who did
not have any of the alternative causes of VHD that made the B
matrices applicable.
In contrast, Matrix B-1 outlines the
compensation available to Diet Drug Recipients with serious VHD
who were registered as having only mild mitral regurgitation by
the close of the Screening Period or who took the drugs for 60
days or less or who had factors that would make it difficult for
them to prove that their VHD was caused solely by the use of
these Diet Drugs.
-2-

suffered from moderate mitral regurgitation, an abnormal left
atrial dimension, and a reduced ejection fraction in the range of
SO% to 60%. 3

Based on such findings, claimant would be entitled

to Matrix A-1, Level II benefits in the amount of $496,153. 4
In the report of claimant's echocardiogram, Dr. Pedulla
stated that claimant had moderate mitral regurgitation, which he
measured at 33.5%.

Under the definition set forth in the

Settlement Agreement, moderate or greater mitral regurgitation is
present where the Regurgitant Jet Area ("RJA") in any apical view
is equal to or greater than 20% of the Left Atrial Area ("LAA").
See Settlement Agreement

§

I.22.

atrial enlargement (5.35 em)

Dr. Pedulla also stated, "Left

-parasternal long axis view."

The

Settlement Agreement defines an abnormal left atrial dimension as
a left atrial supero-inferior systolic dimension greater than
5.3 em in the apical four chamber view or a left atrial
antero-posterior systolic dimension greater than 4.0 em in the
parasternal long axis view.

See id.

§

IV.B.2.c. (2) (b)ii).

Dr. Pedulla also measured claimant's ejection fraction to be 57%.
An ejection fraction is considered reduced for purposes of a

3. Dr. Pedulla also attested that claimant suffered from New
York Heart Association Functional Class I symptoms. This
condition is not at issue in this claim.
4. Under the Settlement Agreement, an eligible class member is
entitled to Level II benefits for damage to the mitral valve if
he or she is diagnosed with moderate or severe mitral
regurgitation and one of five complicating factors delineated in
the Settlement Agreement. See Settlement Agreement
§ IV.B.2.c. (2) (b).
An abnormal left atrial dimension and a
reduced ejection fraction are each one of the complicating
factors necessary for a Level II claim.
-3-

mitral valve claim if it is measured as less than or equal to
60%.

See id. § IV.B.2.c. (2) (b)iv).
In February, 2004, the Trust forwarded the claim for

review by David B. Lieb, M.D., F.A.C.C., one of its auditing
cardiologists.

In audit, Dr. Lieb concluded that there was a

reasonable medical basis for Dr. Pedulla's findings that claimant
had moderate mitral regurgitation, an abnormal left atrial
dimension, and a reduced ejection fraction in the range of SO% to
60%.
Based on Dr. Lieb's findings,

the Trust issued a

post-audit determination awarding Mr. Yeary Matrix Benefits.
Before the Trust paid Mr. Yeary's claim, we imposed a stay on the
processing of claims pending implementation of the Seventh
Amendment to the Settlement Agreement.
("PTO") No. 3511 (May 10, 2004).

See Pretrial Order

Prior to the entry of the stay,

the Trust identified 968 Matrix claims that had passed audit as
payable, which were designated as "Pre-Stay Payable Post-Audit
Determination Letter ('PADL') Claims."

Pursuant to Paragraph 5

of PTO No. 3883, the Trust was ordered to separate the Pre-Stay
Payable PADL Claims into three categories.

Of the 968 Pre-Stay

Payable PADL Claims, the Trust alleged that 580 claims, including
Mr. Yeary's, contained intentional material misrepresentations of
fact.

These 580 claims are commonly referred to as "S(a)

claims."

See PTO No. 3883,

at~

5 (Aug. 26, 2004).

Following the end of the stay, we ordered the Trust to
review the 580 claims designated as S(a) claims and issue new
-4-

post-audit determinations, which claimants could contest.
PTO No. 5625 (Aug. 24, 2005).

See

Prior to the Trust's review of

Mr. Yeary's claim, on November 22, 2006, this court approved
Court Approved Procedure ("CAP") No. 13, which provided 5(a)
claimants with the option either to submit their claims to a
binding medical review by a participating physician or to opt out
of CAP No. 13.

See PTO No. 6707 (Nov. 22, 2006).

Mr. Yeary

elected to opt out of CAP No. 13.
The Trust therefore undertook to determine whether
there were any intentional material misrepresentations of fact
made in connection with Mr. Yeary's claim.

As part of this

review, the Trust engaged Joseph Kisslo, M.D., to review the
integrity of the echocardiogram system used during the
performance of echocardiographic studies and the resulting
interpretations submitted in support of Mr. Yeary's claim.

As

stated in his January 23, 2007 declaration, Dr. Kisslo
determined, in pertinent part, that:
In Mr. Yeary's study, the use of color
persistence and the overmeasurement of the
mitral "jet," as well as the undermeasurement
of the left atrial area and the
overmeasurement of the left atrial dimension
are the result of deliberate choices and
conduct engaged in by the sonographer
performing this study and at a minimum,
acquiesced in by the Attesting Physician.
Each of these manipulations exaggerated or
created the appearance of regurgitation, jet
duration or a complicating factor.
Mr. Yeary
has only mild mitral regurgitation. 5

5.

In November, 2004, the Trust had provided Mr. Yeary with an
(continued ... )
-5-

Thus, notwithstanding Dr. Lieb's findings at audit, the
Trust rescinded its prior post-audit determination letter and
issued a new post-audit determination denying Mr. Yeary's claim
based on its conclusion that there was substantial evidence of
intentional material misrepresentations of fact in connection
with the claim.

Pursuant to the Rules for the Audit of Matrix

Compensation Claims ("Audit Rules"), Mr. Yeary contested this
adverse determination. 6

In contest, Mr. Yeary argued that the

Trust did not satisfy its burden pursuant to PTO No. 3883, Audit
Rule 23, or Rule 9(b) of the Federal Rules of Civil Procedure
with respect to its claim of intentional material
misrepresentations of fact because Dr. Kisslo:

(1) failed to

explain in his declaration whether he is referring to Mr. Yeary's
claim, claims in which Dr. Pedulla served as the attesting

5.
( ... continued)
"Expert Report" signed by Dr. Kisslo pursuant to Paragraph 11 of
PTO No. 3883.
In that report, Dr. Kisslo opined that claimant's
echocardiogram "evidences a misrepresentation of the severity of
mitral regurgitation." Dr. Kisslo explained, "I have concluded
that the reliance on non-regurgitant flow and the tracing of the
mitral regurgitation jet outside any color boundary resulted in a
significant misrepresentation of the size of the mitral
regurgitant jet so as to render it clinically unreliable.
I have
further concluded that the diagnosis of moderate mitral
regurgitation by the Attesting Physician on this study
significantly misrepresented the level of regurgitation and is
beyond the bounds of medical reason."
6.
Claims placed into audit on or before December 1, 2002 are
governed by the Policies and Procedures for Audit and Disposition
of Matrix Compensation Claims in Audit, as approved in PTO
No. 2457 (May 31, 2002).
Claims placed into audit after
December 1, 2002 are governed by the Audit Rules, as approved in
PTO No. 2807 (Mar. 26, 2003). There is no dispute that the Audit
Rules contained in PTO No. 2807 apply to Mr. Yeary's claim.
-6-

physician, or all post-audit determination letters that had been
issued prior to the stay;

(2) used the term "color persistence,"

which is not defined or mentioned in the relevant medical
literature; and (3) referred to "incorrect measurements and
incorrect settings" without identifying the correct measurements
or settings.

In addition, claimant asserted that while

Dr. Kisslo suggested Mr. Yeary's mitral regurgitation was not
correctly measured, the court has approved "eyeballing" the
regurgitant jet to assess severity.

Mr. Yeary also contended

that Dr. Kisslo's selection of a representative jet was
inconsistent with the Weyman text, which, according to claimant,
states that "the maximum jet area occurring at any point during
systole is taken as the representative valve" and requires focus
on "instantaneous, not cumulative, jet parameters."
Mr. Yeary further argued that the Trust cannot prove
that he, or anyone involved in his claim, made any intentional
material misrepresentations of fact in connection with his claim.
In support, Mr. Yeary included declarations from himself, his
attorney, Dr. Pedulla, and the sonographer who performed his
echocardiogram, wherein they each denied any knowledge of a
intentional material misrepresentation of fact relating to the
performance or interpretation of claimant's echocardiogram.
In addition, claimant submitted a response of
Dr. Pedulla to Dr. Kisslo's January 23, 2007 declaration.

In his

response, Dr. Pedulla opined that Mr. Yeary's RJA/LAA ratio is
21%, even when adjusting for overtracing of the RJA and
-7-

underestimation of the LAA.

Claimant also included a declaration

of Kacy Beamish, a second sonographer Mr. Yeary retained to opine
on his level of mitral regurgitation.

In her declaration,

Ms. Beamish stated, "I reviewed the tape and advised [claimant's
counsel] that in my opinion the echocardiogram did demonstrate
mitral regurgitation of 20% or greater." 7
The Trust then issued a final post-audit determination,
again denying Mr. Yeary's claim.

The Trust argued that Mr. Yeary

misinterpreted the legal obligations under Audit Rules, and that
"[t]he burden of proof remains on the Claimant throughout these
proceedings" to establish that there is a reasonable medical
basis in support of his claim - not on the Trust to prove that an
intentional material misrepresentation of fact exists.

The Trust

also asserted that Mr. Yeary's contest does not satisfy this
burden because, while it raised numerous contentions and
criticisms pertaining to Dr. Kisslo's declaration, neither

7.
Claimant also incorporated by reference a September 8, 2005
letter from Class Counsel to the Trust.
In this letter, Class
Counsel argued, among other things, that the Trust could not deny
payment on any claim in which a post-audit determination letter
had been sent unless it found that the claim was based on a
fraudulent echocardiogram and that the Trust could not rely on
the reports of Dr. Kisslo to determine whether a claim in which a
post-audit determination letter had been sent was fraudulent.
The issues raised in Class Counsel's letter also were the subject
of a motion filed by Class Counsel and joined by a number of
firms representing various Class Members.
Class Counsel and all
but one firm subsequently withdrew the motion after the adoption
of certain Court Approved Procedures. We denied the motion of
the remaining firm following briefing and argument.
See PTO
No. 6099 (Mar. 31, 2006).
-8-

claimant nor Dr. Pedulla specifically identified any alleged
errors in Dr. Kisslo's findings.
In addition, the Trust contended that claimant's
challenge to Dr. Kisslo's use of the term "color persistence" in
his declaration was misplaced since it signifies the importance
of jet duration in determining moderate mitral regurgitation, as
opposed to the "isolated instances of moderately sized jets"
exhibited in claimant's echocardiogram.

Lastly, the Trust

rejected Dr. Pedulla's representation that any overmeasurement
should be viewed as an unintentional error.

Instead, the Trust

argued that the "jet overtracing, generally represented by
tracing outside of jet borders and the inclusion of entrainment
(low velocity flow)" depicted in Mr. Yeary's study were not
simply "the result of random error within reasonable range," but,
instead, one instance in a pattern of "distinct recurrent
manipulations" that Dr. Kisslo observed in the echocardiograms
performed by the company that completed claimant's
echocardiogram.
Mr. Yeary disputed the Trust's final determination and
requested that his claim proceed through the show cause process
established in the Settlement Agreement.

See Settlement

Agreement§ VI.E.7.; PTO No. 2807, Audit Rule 18(c).

The Trust

then applied to the court for issuance of an Order to show cause
why Mr. Yeary's claim should be paid.

On July 13, 2007, we

issued an Order to show cause and referred the matter to the

-9-

Special Master for further proceedings.

See PTO No. 7314

(July 13, 2007).
Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
documentation.
Master.

Claimant then served a response upon the Special

The Trust submitted a reply on November 9, 2007, and

claimant submitted a sur-reply on May 8, 2008.

Under the Audit

Rules, it is within the Special Master's discretion to appoint a
Technical Advisor 8 to review claims after the Trust and claimant
have had the opportunity to develop the Show Cause Record.
Audit Rule 30.

See

The Special Master assigned Technical Advisor,

Gary J. Vigilante, M.D., F.A.C.C., to review the documents
submitted by the Trust and claimant and prepare a report for the
court.

The Show Cause Record and Technical Advisor Report are

now before the court for final determination.

See id. Rule 35.

The issue presented for resolution of this claim is
whether claimant has met his burden of proving that there is a
reasonable medical basis for Mr. Yeary's claim. 9

Where the

8. A "[Technical] [A]dvisor's role is to act as a sounding board
for the judge-helping the jurist to educate himself in the jargon
and theory disclosed by the testimony and to think through the
critical technical problem." Reilly v. United States, 863 F.2d
149, 158 (1st Cir. 1988).
In a case such as this, where
conflicting expert opinions exist, it is within the discretion of
the court to appoint a Technical Advisor to aid it in resolving
technical issues.
Id.
9. Given our resolution with respect to whether there is a
reasonable medical basis for the attesting physician's finding
that Mr. Yeary suffered from moderate mitral regurgitation, we
(continued ... )
-10-

Trust's post-audit determination finds intentional material
misrepresentations of fact, the claimant has the burden of
proving that all representations of material fact in connection
with his claim are true.

See id. Rule 24.

Ultimately, if we

determine that there is no reasonable medical basis for the
answers in claimant's Green Form either because of an intentional
material misrepresentation of fact or some other valid reason, we
must affirm the Trust's final determination and may grant such
other relief as deemed appropriate.

See id. Rule 38(a).

If, on

the other hand, we determine that there is a reasonable medical
basis for the answers with no intentional material
misrepresentations of fact made in connection with the claim, we
must enter an Order directing the Trust to pay the claim in
accordance with the Settlement Agreement.

See id. Rule 38(b).

In support of his claim, Mr. Yeary incorporated the
arguments he made at contest.

In addition, he asserts that PTO

No. 3883 only "authorized non-payment of the [post-audit
determination letters] in those instances where the Trust could
prove there had been an 'intentional manipulation of

echocardiogram tape,'" and did not authorize a second audit of
his claim (emphasis in original).

Thus, Mr. Yeary contends that

the Trust must first prove that there was an intentional material
misrepresentation of fact in connection with his claim before we

9.
( ... continued)
need not determine whether there is a reasonable medical basis
for finding that he suffered from an abnormal left atrial
dimension or a reduced ejection fraction.
-11-

may consider whether Mr. Yeary has a compensable level of mitral
regurgitation.
In response, the Trust argues that it did not re-audit
Mr. Yeary's claim.

According to the Trust, Dr. Kisslo attempted

to "read through" the misrepresentations in connection with
Mr. Yeary's claim to determine whether they were material.

The

Trust also contends that the review provided for by PTO No. 3883
does not apply only to frame insertions and similar
echocardiogram tape manipulations.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's echocardiogram and concluded that it was not conducted
in a manner consistent with medical standards.

Specifically,

Dr. Vigilante observed:
All of the usual echocardiographic views were
obtained. However, the images were not
conducted in a manner consistent with medical
standards. There was excessive color gain
with color artifact noted even within the
myocardial tissue.
Low velocity flow was
inappropriately highlighted in this study.
In addition, color persistence was noted with
the inappropriate appearance of mitral
regurgitation occurring during diastole
during several cardiac cycles.
Despite these deficiencies, Dr. Vigilante noted that he
was able to evaluate claimant's echocardiogram and determined
that there was no reasonable medical basis for the attesting
physician's finding that claimant had moderate mitral
regurgitation.

Dr. Vigilante explained, in pertinent part, that:

Evaluation of the mitral regurgitation jet
occurred in both the apical four chamber and
apical two chamber views. The mitral
-12-

regurgitation jet appeared most impressive in
the apical four chamber view. However, there
was some artifact due to excessive color gain
and persistence.
I digitized the cardiac
cycles in the apical four chamber and apical
two chamber views during color flow
evaluation.
In spite of color artifact, I
was able to accurately planimeter the RJA in
several cardiac cycles. The largest RJA was
4.0 cm2. This determination was made in the
apical four chamber view. Most of the RJA
determinations were much less than this
value. The RJA was less than 3.0 cm2 in the
apical two chamber view.
I was also able to
accurately planimeter the LAA. This
measurement was performed in the same cardiac
cycle in which the sonographer planimetered
the LAA.
I determined that the LAA was
24.3 cm2. Therefore, the largest RJA/LAA
ratio was less than 17%. The RJA/LAA ratio
never approached 20%. Therefore, I
determined that, at worst, only mild mitral
regurgitation was present on this study.
I
reviewed the sonographer's measurements on
the study. Two supposed RJA's were measured
by the sonographer. The measurements were
7.23 cm2 and 9.42 cm2. The sonographer's
measurement of 7.23 cm2 is inaccurate by
inclusion of significant low velocity
non-mitral regurgitation jet flow within this
measurement. The true RJA measurement in
this frame was 3.9 cm2. The second
sonographer's RJA measurement of 9.42 cm2 is
completely inaccurate. This cardiac frame is
not even demonstrating mitral regurgitation
and is taken in the wrong phase of the
cardiac cycle.
I also reviewed the
sonographer's LAA measurement of 23.2 cm2.
This measurement was inaccurate and small as
it did not include part of the
postero-lateral aspect of the atrium.
In response to the Technical Advisor Report, Mr. Yeary
reiterates his belief that the issue in his claim is not whether
there is an appropriate level of mitral regurgitation but whether
there are intentional material misrepresentations of fact in
connection with his claim.

He also argues that this case is
-13-

merely "a difference of opinion between experts" rather than an
instance of intentional material misrepresentation of fact
contemplated by PTO No. 3883.

In addition, Mr. Yeary contends

that the Trust did not comply with PTO No. 3883 because it did
not identify, with the specificity required by Rule 9(b) of the
Federal Rules of Civil Procedure, the alleged intentional
material misrepresentation of fact in connection with this claim.
Finally, Mr. Yeary asserts that Dr. Vigilante's findings with
respect to excessive color gain should be excluded because they
were raised for the first time in the Technical Advisor Report.
After reviewing the entire Show Cause Record, we find
claimant has not established a reasonable medical basis for the
attesting physician's finding that Mr. Yeary had moderate mitral
regurgitation.

In reaching this determination, we are required

to apply the standards delineated in the Settlement Agreement and
Audit Rules.

In the context of those two documents, we

previously have explained that conduct "beyond the bounds of
medical reason" can include:
loops and still frames;

(1) failing to review multiple

(2) failing to have a Board Certified

Cardiologist properly supervise and interpret the echocardiogram;
(3) failing to examine the regurgitant jet throughout a portion
of systole;

(4) over-manipulating echocardiogram settings;

(5) setting a low Nyquist limit;

(6) characterizing "artifacts,"

"phantom jets," "backflow" and other low velocity flow as mitral
regurgitation;

(7) failing to take a claimant's medical history;

and (8) overtracing the amount of a claimant's regurgitation.
-14-

See Mem. in Supp. of PTO No. 2640, at 9-13, 15, 21-22, 26
(Nov . 14

I

2 002 ) .
Here, Dr. Kisslo and Dr. Vigilante each found that

claimant's sonographer improperly selected, traced, and measured
a supposed regurgitant "jet."

According to Dr. Vigilante, the

first supposed RJA measured by the sonographer included
"significant low velocity non-mitral regurgitation jet flow"
while the second RJA measured by the sonographer was "completely
inaccurate" because it was "taken in the wrong phase of the
cardiac cycle" and "is not even demonstrating mitral
regurgitation."

In addition, Dr. Kisslo and Dr. Vigilante

determined that the sonographer underestimated claimant's LAA,
which artificially increased the supposed level of Mr. Yeary's
mitral regurgitation.

Finally, Dr. Kisslo and Dr. Vigilante

found that the echocardiogram of attestation was not conducted in
a manner consistent with medical standards because, among other
things, the echocardiogram settings included the use of color
persistence to exaggerate the appearance of mitral
regurgitation. 10
Notwithstanding these deficiencies, Dr. Kisslo and
Dr. Vigilante determined that Mr. Yeary's echocardiogram
demonstrated only mild mitral regurgitation.

In addition,

10. Claimant's objection to use of the term "color persistence"
because it is undefined is misplaced.
In fact, the Trust
provided in its final post-audit determination a detailed
explanation of the term and how it applied specifically in the
declaration of Dr. Kisslo.
-15-

Dr. Vigilante concluded, after a thorough review, that there was
no reasonable medical basis for the attesting physician's opinion
that Mr. Yeary had moderate mitral regurgitation.

Specifically,

he explained that "the largest RJA/LAA ratio was less than 17%"
and that "[t]he RJA/LAA ratio never approached 20%."
Claimant does not substantively challenge the specific
findings of Dr. Kisslo or Dr. Vigilante regarding the manner in
which his echocardiogram was conducted.

With respect to the

manner in which his level of mitral regurgitation was evaluated,
claimant, relying on declarations of Dr. Pedulla and Ms. Beamish,
contends that his RJA/LAA ratio is moderate even taking into
account the overmeasurement of his RJA and undermeasurement of
his LAA.

We disagree.

Dr. Kisslo reviewed claimant's

echocardiogram and determined it actually demonstrated only mild
mitral regurgitation. 11

In addition, Dr. Vigilante reviewed the

record, including Dr. Pedulla's declaration, and determined that
Mr. Yeary's level of mitral regurgitation was less than 17%.

In

particular, Dr. Vigilante noted, "An echocardiographer could not
reasonably conclude that moderate mitral regurgitation was
present on this study even taking into account inter-reader

11. We reject claimant's argument that Dr. Kisslo's challenge to
the way in which Mr. Yeary's RJA and LAA were measured is
irrelevant because we have approved the use of eyeballing to
determine the level of mitral regurgitation. We never have ruled
that simply eyeballing a jet can provide a reasonable medical
basis for the attesting physician's determination of moderate
mitral regurgitation where, as here, the auditing cardiologist
and the Technical Advisor have reviewed claimant's echocardiogram
and determined it demonstrates only mild mitral regurgitation.
-16-

variability when recognizing the inappropriate conduct of the
echocardiogram study. " 12
We also disagree with claimant's argument that one
measurement of a maximum, instantaneous jet rather than a
representative jet may form the basis for matrix Benefits.

We

previously have held that "[f) or a reasonable medical basis to
exist, a claimant must establish that the findings of the
requisite level of mitral regurgitation are representative of the
level of regurgitation throughout the echocardiogram."

Mem. in

Supp. of PTO No. 6997, at 11 (Feb. 26, 2007); see also In re Diet
Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Prods. Liab.
Litig., 543 F.3d 179, 187 (3d Cir. 2008).

"To conclude otherwise

would allow claimants who do not have moderate or greater mitral
regurgitation to receive Matrix Benefits, which would be contrary
to the intent of the Settlement Agreement."

See Mem. in Supp. of

PTO No. 6997, at 11.
We also reject claimant's argument that the review of
his claim by Dr. Kisslo constitutes an impermissible second
audit.

This argument ignores the plain language of the Audit

Rules, which provides that the Trust must conduct a review
separate from the auditing cardiologist with respect to whether
there were any intentional material misrepresentations of fact in
connection with a claim.

Specifically, the Audit Rules state, in

pertinent part, that:

12. Thus, we reject claimant's argument that this case is merely
"a difference of opinion between experts."
-17-

The Auditing Cardiologist shall review a
Claim in accordance with these Rules to
determine whether there was a reasonable
medical basis for each answer in Part II of
the GREEN Form that differs from the Auditing
Cardiologist's finding on that specific issue
("GREEN Form Question at Issue"). The Trust
shall review a Claim to determine whether
there were any intentional material
misrepresentations made in connection with
the Claim. The Trust may consider
information from other Claims in Audit to
determine the existence of facts or a pattern
of misrepresentations implicating intentional
misconduct by an attorney and/or physician
that may warrant relief pursuant to Section
VI.E.8 of the Settlement Agreement.
Audit Rule 5.

Based on the findings of Dr. Kisslo, the Trust

denied Mr. Yeary's claim, determining that the claim was based on
one or more intentional material misrepresentations of fact.
Mr. Yeary disputed this determination and proceeded to
the show cause process.

We need not determine whether there was,

in fact, any intentional material misrepresentation of fact in
connection with Mr. Yeary's claim given our conclusion.

Based on

our review of the entire record, there is no reasonable medical
basis for Dr. Pedulla's representation that claimant had moderate
mitral regurgitation . 13
For the foregoing reasons, we conclude that claimant
has not met his burden of proving that there is a reasonable

13. As we previously have stated, "[s]imply because an
undeserving claim has slipped through the cracks so far is no
reason for this court to put its imprimatur on a procedure which
may allow it to be paid." Mem. in Supp. of PTO No. 5625 at 6-7
(Aug. 24, 2005). In this same vein, we will not ignore the
findings of other cardiologists simply because a claim has
previously passed audit.
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medical basis for finding that he had moderate mitral
regurgitation.

Therefore, we will affirm the Trust's denial of

Mr. Yeary's claim for Matrix Benefits.

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