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

Filing 5279

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9477 RE: TAMMY RADANDT. SIGNED BY HONORABLE HARVEY BARTLE, III ON 9/30/2016. 9/30/2016 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110573 IN 11-MD-1203) (ems)

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

MDL NO. 1203

THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.

CIVIL ACTION NO. 99-20593

v.
AMERICAN HOME PRODUCTS
CORPORATION

2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

qy11

September 30, 2016

Bartle, J.

Tammy Radandt ("Ms. Radandt" 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 ort the record

developed in the show cause process, we must determine whether
claimant has demonstrated a reasonable medical basis to support
her claim for Matrix Compensation Benefits ("Matrix Benefits") . 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
(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").
(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 must complete Part III

if claimant is represented.
In October 2013, claimant submitted a supplemental
Green Form to the Trust signed by her attesting physician,
Martin G. Keane, M.D.

("Dr. Keane") . 3

Based on an echocardiogram

dated February 3, 2002, Dr. Keane attested in Part II of Ms.
Radandt's Green Form that claimant had severe mitral
regurgitation, surgery to repair or replace the aortic and/or

( ... continued)
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.
3.
In April, 2014, claimant submitted an amended Part II of the
Green Form. This submission is the basis for the present claim.

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2 -

mitral valve(s) following the use of Pondimin® and/or Redux™, New
York Heart Association Functional Class II symptoms,
ventricular ejection fraction

<

4

and a left

40% at any time six months or

later after valvular repair or replacement surgery. 5

Based on

such findings, claimant would be entitled to Matrix A-1, Level
IV 6 benefits in the amount of $966,820.45. 7
Dr. Keane also attested that Ms. Radandt did not
suffer from mitral annual calcification or a rheumatic mitral

4. Although Dr. Keane initially attested that Ms. Radandt
suffered from New York Heart Association Functional Class IV
symptoms, he subsequently stated-and claimant conceded - that
she suffered from New York Heart Association Functional Class II
symptoms.
5. Dr. Keane also attested that claimant suffered from
pulmonary hypertension secondary to moderate or greater mitral
regurgitation and an abnormal left ventricular dimension. These
conditions are not at issue in this claim.
6. Under the Settlement Agreement, a claimant is entitled to
Level IV benefits if he or she qualifies for payment at Matrix
Level III, has New York Heart Association Functional Class I or
Class II symptoms, underwent surgery to repair or replace the
aortic and/or mitral valve(s), and had a left ventricular
ejection fraction of less than 40% six months or later after
valvular repair or replacement surgery. See Settlement
Agreement § IV.B.2.c. (4) (c).
The Trust does not dispute that
Ms. Radandt qualifies for payment at Matrix Level III, has New
York Heart Association Functional Class II symptoms, and
underwent mitral valve surgery.
7. Ms. Radandt previously received Seventh Amendment Category
One Benefits in the amount of $180,170.55. According to the
Trust, if entitled to Matrix A-1, Level IV benefits, claimant
would be entitled to Matrix Benefits in the amount of
$1,146,991. The amount at issue, therefore, is the difference
between the Category One Benefits already paid and the amount of
Matrix A-1, Level IV benefits. See id. § IV.C.3.

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valve.

Under the Settlement Agreement, the presence of either

of these conditions requires the payment of reduced Matrix
Benefits for a claim based on damage to the mitral valve.
id.

§§

See

IV.B.2.d. (2) (c)ii)d), IV.B.2.d. (2) (c)ii)e) . 8
In May 2014, the Trust forwarded the claim for review

by Waleed N. Irani, M.D., F.A.C.C., F.A.S.E.
of its auditing cardiologists.

("Dr. Irani"), one

Dr. Irani accepted the attesting

physician's conclusion that Ms. Radandt suffered from the
conditions necessary for Level IV Matrix Benefits.

However, he

also found that there was no reasonable medical basis for Dr.
Keane's finding that claimant did not have mitral annual
calcification.

Pursuant to Court Approved Procedure ("CAP")

No. 11, the Consensus Expert Panel 9 subsequently reviewed
Ms. Radandt's claim and determined that the claim should be
re-audited because the "[g]roup finds
basis]

[a reasonable medical

for [the] attesting physician's finding of no mitral

8.
If Ms. Radandt's supplemental claim Matrix Benefits is
payable only on Matrix B-1, she will not receive any additional
payment because the amount to which she would be entitled is
less than the amount of Category One Benefits she previously
received pursuant to the Seventh Amendment.
9. The Consensus Expert Panel consists of three cardiologists,
one designated by each of Class Counsel, the Trust, and Wyeth.
See Pretrial Order ("PTO") No. 6100 (Mar. 31, 2005). We
approved creation of the Consensus Expert Panel to "monitor the
performance of the Auditing Cardiologists and to develop
procedures for quality assurance in the Audit of Claims for
Matrix Compensation Benefits." Id.

-

4

-

annular calcification."

In October 2014, the Trust informed Ms.

Radandt that it had accepted the Consensus Expert Panel's
recommendation that her claim be re-audited.
In June 2015, the Trust forwarded the claim for review
by another auditing cardiologist, Zuyue Wang, M.D., F.A.C.C.,
F.A.S.E.

("Dr. Wang").

In audit, Dr. Wang concluded that there

was no reasonable medical basis for finding that claimant had an
ejection fraction of less than 40% six months or later after her
mitral valve surgery.

Dr. Wang explained:

The claimant did not have a 6 month
[echocardiogram] ; her [echocardiogram] on
3/26/12 (9 months post-op) showed [an]
[ejection fraction] of 65%.
Dr. Wang also determined that there was no reasonable medical
basis for Dr. Keane's finding that claimant did not have a
rheumatic mitral valve.

Dr. Wang observed:

There are many [echocardiographic] features
of rheumatic mitral valve disease:
1) leaflets thickening especially at the
tip, with diastolic doming[,] 2) chordal
thickening, 3) restricted motion of
posterior mitral leaflet, 4) commissural
fusion, 5) moderate to severe mitral
stenosis with mitral valve area of 1.6cm2.
Based on Dr. Wang's findings, the Trust issued a
post-audit determination that Ms. Radandt was not entitled to
supplemental Matrix Benefits.

Pursuant to the Rules for the

Audit of Matrix Compensation Claims ("Audit Rules"), claimant

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contested these adverse determinations. 10

In contest,

Ms. Radandt argued that there was a reasonable medical basis for
finding that she was entitled to Matrix A, Level IV benefits.
In addition, claimant stated that "[a) mere difference of
opinion is not sufficient to deny this claim."

She also argued

that the auditing cardiologist substituted her subjective
opinion for the opinion of the attesting physician.
With respect to whether her ejection fraction was less
than 40% six months or later after her mitral valve surgery,
claimant argued that "while the Auditing Cardiologist and [Jay
N. Schapira, M.D., F.A.C.C., F.A.C.P., F.C.C.P., F.A.H.A.

("Dr.

Schapira")] agree that the March 2012 echocardiogram shows a
[left ventricular ejection fraction]
echocardiogram report indicated a
fraction]

over 40%, the March 2012

[left ventricular ejection

of 40% and Ms. Radandt had a

ejection fraction]

[left ventricular

of 20-25% over five and

~

months after her

surgery."

10. 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 Ms. Radandt's
claim.

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With respect to whether she had a rheumatic mitral
valve, claimant contended that "it is very difficult to
establish that the Attesting Physician's findings and answer
[is] devoid of any reasonable medical basis" because there is
not a diagnosis of rheumatic mitral valve in any of her medical
records.

In addition, Ms. Radandt submitted a number of medical

records and a letter from Dr. Schapira, wherein he stated:
I do not find M-mode and/or 2D
echocardiographic evidence of rheumatic
valvular heart disease.
I carefully
reviewed the VHS tape dated 2-23-02 and in
my opinion this showed no evidence of
rheumatic disease in the mitral valve:
no
fusion, no mitral stenosis and no doming of
the mitral leaflets was present.
Subsequent transthoracic echocardiographic
studies, including September 24, 2009 and
August 26, 2010, also revealed no sign of
rheumatic valve disease.
There was no
gradient on spectral Doppler across the
mitral valve in either study and therefore
no mitral stenosis.
Clearly, these studies
do not show evidence of a rheumatic valve
disease and I disagree with the conclusion
of the auditor.
The pathological diagnosis of the mitral
valve at the time of Tammy Radant's [sic]
mitral valve replacement surgery was that of
"fibromyxoid degeneration," again not
consistent with rheumatic disease.

My opinion is that to a reasonable degree of
medical certainty, Tammy Radant's [sic]
mitral valve disease was due to her diet
drug exposure.

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Although not required to do so, the Trust forwarded
the claim for another review by the auditing cardiologist.
Dr. Wang submitted a declaration in which she again concluded
that Ms. Radandt did not have an ejection fraction of less than
40% six months or later after her mitral valve surgery.
Specifically, Dr. Wang stated:
Claimant underwent mitral valve surgery on
June 1, 2011.
The March 26, 2012
echocardiogram, which is the sole
echocardiogram performed six months or more
after Claimant's surgery, shows an ejection
fraction of 60-65%. Even Dr. Schapira found
an ejection fraction of greater than 50% at
the time of the March 2012 study.
I do not
agree with the assertion at Contest that,
because the November 11, 2011 report
indicates an ejection fraction of 20-25%,
Claimant's ejection fraction must have been
less than 40% six months or more after
surgery.
It is likely that Claimant's
ejection fraction improved in the weeks
preceding the six month cut off. There are
no medical records documenting an ejection
fraction below 40% at any time six months or
later after mitral valve surgery.
Dr. Wang also confirmed her finding that there was no reasonable
medical basis for Dr. Keane's representation that Ms. Radandt
did not have echocardiographic evidence of a rheumatic mitral
valve.

She explained:
I observed thickening at the tip of the
mitral leaflets with diastolic doming, mild
fusion of chordae and commissure which
resulted in mild mitral stenosis with mitral
valve area of 2.2cm2 by pressure half time
method.
(A normal mitral valve area is 46cm2).
Claimant had mild mitral stenosis

-

8 -

and severe mitral regurgitation, which is
consistent with rheumatic heart valves
rather than Diet Drug valvulopathy. The
pathology report does not rule out rheumatic
valve disease.
The Trust then issued a final post-audit determination
that Ms. Radandt was not entitled to supplemental Matrix
Benefits.

Claimant disputed this final determination and

requested that the claim proceed to 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 Ms. Radandt's claim should be paid.

On October 5, 2015, we

issued an Order to show cause and referred the matter to the
Special Master for further proceedings.

See PTO No. 9439

( Oct . 5 , 2 O15 ) .
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 January 5, 2016.

Under

the Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor 11 to review claims after the Trust

11. 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 problems." Reilly v. United
States, 863 F.2d 149, 158 (1st Cir. 1988).
In a case such as
(continued ... )
- 9 -

and claimant have had the opportunity to develop the show cause
record.

See Audit Rule 30.

The Special Master assigned a

Technical Advisor, Gary J. Vigilante, M.D., F.A.C.C.

("Dr.

Vigilante"), to review the documents submitted by the Trust and
claimant and to 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 issues presented for resolution of this claim are
whether claimant has met her burden of proving that there is a
reasonable medical basis for the attesting physician's findings
that Ms. Radandt (1) had an ejection fraction less than 40% at
any time six months or later after valvular repair or
replacement surgery and (2) did not have echocardiographic
evidence of a rheumatic mitral valve.

See id. Rule 24.

Ultimately, if we determine that there is no reasonable medical
basis for the answers in claimant's Green Form that are at
issue, we must affirm the Trust's final determination and may
grant such other relief as deemed appropriate.
Rule 38(a).

See id.

If, on the other hand, we determine that there is a

reasonable medical basis for the answers, we must enter an Order

( ... continued)
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.

- 10 -

directing the Trust to pay the claim in accordance with the
Settlement Agreement.

See id. Rule 38(b).

In support of her claim, Ms. Radandt reasserts the
arguments she raised in contest.

She points to Dr. Keane's

representation that Ms. Radandt had an ejection fraction of less
than 40% six months or later after her mitral valve surgery.
She argues that there is a reasonable medical basis for the
finding.

Even though claimant did not have an echocardiogram

performed exactly six months after her mitral valve surgery, she
asserts that "it is unlikely that [her]

[left ventricular

ejection fraction] would have climbed 16-21% in a matter of
eleven days."
With respect to Dr. Keane's representation that Ms.
Radandt did not have a rheumatic mitral valve, claimant
maintains that it has a reasonable medical basis since neither
the surgeon nor the cardiologist diagnosed Ms.Radandt with
rheumatic mitral valve and both of them attributed her condition
to Diet Drug use.
In addition, claimant asserts that she has never had
rheumatic fever and that chordal thickening and shortening and
thickening of leaflets are seen in patients with drug-induced
valvular heart disease.
Finally, claimant contends that "[t]he clinical
diagnoses and medical opinions of a Claimant's treating board-

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significant weight when determining if a Claimant has met
his/her burden."
In response, the Trust argues that Dr. Wang, as well
as claimant's own expert, Dr. Schapira, reviewed the only
echocardiogram performed more than six months after claimant's
mitral valve surgery and determined that it demonstrated an
ejection fraction that was greater than 40%.

Further, the Trust

asserts that the absence of any reference to rheumatic mitral
valve in the pathology report and the absence of a diagnosis of
rheumatic fever are insufficient to overcome the
echocardiographic evidence of rheumatic mitral valve.

Finally,

the Trust contends that claimant's treating physicians are not
entitled to any deference in the audit process.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's echocardiograms and concluded that there was no
reasonable medical basis for the attesting physician's finding
that claimant suffered from an ejection fraction less than 40%
six months or later after valvular repair or replacement
surgery.

Specifically, Dr. Vigilante stated, in pertinent part:
I reviewed the Claimant's echocardiogram of
October 26, 2011. All 65 loops/images were
evaluated. This was an excellent quality
study. There was significant dilation of
the left ventricle with severe diffuse
decrease in contractility and an estimated
ejection fraction of 20%.

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I reviewed the CD of the Claimant's
echocardiogram dated March 26, 2012. All 67
loops/images were reviewed.
This was a good
quality study with the usual
echocardiographic views obtained.
I
then calculated the ejection fraction by
Simpson's Method.
I determined that the
left ventricular ejection fraction was
62%.

[T]here is no reasonable medical basis for
the Attesting Physician's answer to Green
Form Question K. That is, the only
echocardiogram performed 6 months or later
after mitral valve replacement surgery
demonstrated a left ventricular ejection
fraction of 62%. This ejection fraction was
not even close to 40%.
It is possible for
an ejection fraction to substantially
increase within one month for a number of
reasons including recovery after cardiac
surgery, improvement in hemodynamics, and
appropriate medical treatment. An
echocardiographer could not reasonably
conclude that an ejection fraction of less
than 40% was present on an echocardiogram
performed 6 months or later after mitral
valve replacement surgery.
Dr. Vigilante also determined that there was no reasonable
medical basis for the attesting physician's finding that
Ms. Radandt did not have a rheumatic mitral valve.

In support

of this conclusion, Dr. Vigilante explained:
I reviewed the DVD and tapes of the
Claimant's Echocardiogram of Attestation.
This study was dated February 3, 2002. All
copies demonstrated the same study.
All 158 loops were reviewed. This was a
below quality study with excessive color
gain.
However, there was adequate
evaluation of the mitral apparatus. This
study demonstrated excellent views of the
- 13 -

mitral valve apparatus particularly in the
view.
There was obvious doming of both
anterior and posterior mitral valve leaflets
as well as thickening of the tips of the
leaflets.
There was commissural fusion.
This was a classic rheumatic mitral
valve.
I reviewed the Claimant's echocardiogram of
July 17, 2003. This was a below average
quality study. However, there was
thickening of both mitral leaflets
particularly the tips of both leaflets.
In
addition, there was classic doming and
commissural fusion .
I also reviewed the Claimant's
echocardiogram of April 21, 2004.
This was
a better quality study than the previous
echocardiogram. This study demonstrated
significant thickening of the mitral
leaflets with obvious doming and commissural
fusion.
Significant mitral stenosis was not
present. This was a classic rheumatic
mitral valve.
I reviewed the Claimant's transesophageal
echocardiogram of August 12, 2008. This
study demonstrated classic doming of the
mitral leaflets and commissural fusion.
The
mitral leaflets were thickened.
There was
severe mitral regurgitation. There was no
significant mitral stenosis. This was a
classic rheumatic mitral valve.
I reviewed the Claimant's echocardiogram
dated September 24, 2009.
I reviewed all 79
loops/images. This was a reasonable quality
study with the usual echocardiographic views
obtained.
There were significant
abnormalities of the mitral valve. There
was moderate thickening of the mitral valve
particularly tips of both leaflets with
definite doming and commissural fusion
classic for rheumatic mitral valvular
disease.
This was best seen in loops 1, 27,
57, and 61.

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I reviewed the Claimant's echocardiogram of
August 26, 2010. All 71 loops/images were
reviewed.
This study was of adequate
quality.
There were marked abnormalities of
the mitral apparatus. There is significant
thickening of the tips and body of both
mitral leaflets. There is obvious doming
and commissural fusion.
This is best seen
in loop 26.
Thickening of the chordal
structures consistent with rheumatic
valvular disease is also obvious on the
parasternal long-axis view best visualized
in loops 2 and 4.
I reviewed the echocardiogram of
October 1, 2010. This was a relatively
limited study with only 17 loops/images.
However, severe abnormalities of the mitral
apparatus could be seen. There was
significant thickening of both mitral
leaflets with doming and commissural fusion.
This was best seen in loops 1, 5, and 6.
Significant thickening of the chordal
structure was seen in loop 10. These
findings are classic for rheumatic mitral
valvular disease.

I reviewed the Claimant's transesophageal
[echocardiogram] of June 11, 2011.
I
reviewed all 14 loops. This was the intraoperative study. The first loop showed
obvious doming of both mitral leaflets as
well as thickening of the tips of the
leaflets. There was obvious commissural
fusion.
Loop 3 demonstrated definite
thickening of the chordae tendineae as well
as severe mitral regurgitation.
This study
was classic for rheumatic mitral valvular
disease.

[T]here is no reasonable medical basis for
the Attesting Physician's answer to Green
Form Question D.10. That is, all of the
Claimant's pre-operative echocardiograms
- 15 -

demonstrate obvious evidence of rheumatic
mitral valves with doming of the anterior
leaflet and commissural fusion with comments
as above. An echocardiographer could not
reasonably conclude that there was no
echocardiographic evidence of rheumatic
mitral valves on these studies.
In
addition, a Board-Certified pathologist has
not determined that there was no evidence of
rheumatic valve disease on pathological
examination of the mitral valve tissue.
Claimant submitted a response to the Technical Advisor
report.

With respect to the level of her ejection fraction,

claimant states that she "does not dispute the fact that [a]
[left ventricular ejection fraction] may substantially increase
in a one-month period of time."

She argues, however, that this

is not dispositive because "Dr. Keane's medical opinion was
that, more likely than not, Ms. Radandt's [left ventricular
ejection fraction] did not jump from 20% on October 26, 2011, to
over 40% by November 10, 2011."

As to whether she had a

rheumatic mitral valve, claimant suggests that we should ignore
Dr. Vigilante's opinion because he says she had a "classic
rheumatic valve," a "broad-brush" term that is not contemplated
by the Settlement Agreement or evaluable by claimant.

She also

concedes that her treating physicians noted a "thickened" mitral
valve in her history, but she simply argues that it is
"consistent with Fen-Phen valvulopathy" and that "an
[echocardiogram]

image is not, by itself, sufficient to diagnose

the presence of rheumatic valve disease."

- 16 -

After reviewing the entire Show Cause Record, we find
that claimant has failed to establish a reasonable medical basis
for her claim.

First, claimant has failed to meet her burden

with respect to establishing a reasonable medical basis for the
attesting physician's Green Form representation that Ms. Radandt
had an ejection fraction of less than 40% six months or later
after valvular repair or replacement surgery.

As an initial

matter, we previously have rejected the argument that a claimant
may rely solely on records of medical procedures performed
within the six month period after her mitral valve surgery to
establish an ejection fraction six months or more after surgery.
See, e.g., Mem. in Supp. of Separate PTO No. 8976, at 8 n.11
(Nov. 28, 2012).
Moreover, claimant's reliance on the only
echocardiogram conducted six months or later after her mitral
valve surgery for evidence that she had an ejection fraction of
less than 40% months earlier is misplaced.

Although Ms. Radandt

points out that the reviewing cardiologist estimated claimant's
ejection fraction to be 40% based on the March 26, 2012
echocardiogram, her own expert, Dr. Schapira, noted that this
echocardiogram demonstrated an ejection fraction of greater than
50%.

In addition, Dr. Wang and Dr. Vigilante reviewed the

echocardiogram and determined that it was actually in the range

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of 60% to 65%. 12

Claimant does not challenge these

determinations that her echocardiogram demonstrates an ejection
fraction much higher than 40%.
In addition, Dr. Vigilante noted - and claimant does
not dispute -

that "[i]t is possible for an ejection fraction to

substantially increase within one month for a number of reasons
including recovery after cardiac surgery, improvement in
hemodynamics, and appropriate medical treatment."

We do not

accept claimant's argument that this possibility "is not
controlling" because Dr. Keane's opinion was that it was "more
likely than not" that Ms. Radandt's ejection fraction "did not
jump from 20% on October 26, 2011, to over 40% by November 10,
2011."

Claimant's ejection fraction was well over 40% on the

only echocardiogram that was performed more than six months
following her mitral valve surgery.

Under the circumstances of

this case, claimant has failed to establish a reasonable medical
basis for her attesting physician's finding that she had an
ejection fraction of less than 40% six months or later after her
mitral valve surgery.
Second, claimant has failed to meet her burden with
respect to establishing a reasonable medical basis for the

12.
For this reason as well, we reject claimant's argument that
the auditing cardiologist simply substituted her opinion for the
opinion of the attesting physician.

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attesting physician's Green Form representation that Ms. Radandt
did not have a rheumatic mitral valve.

The Settlement Agreement

provides that a claimant will receive reduced Matrix Benefits
when certain enumerated medical conditions are present,
including a rheumatic mitral valve defined as follows:
M-Mode and 2-D echocardiographic evidence of
rheumatic mitral valves (doming of the
anterior leaf let and/or anterior motion of
the posterior leaflet and/or commissural
fusion), except where a Board-Certified
Pathologist has examined mitral valve tissue
and determined that there was no evidence of
rheumatic valve disease.
Settlement Agreement

§

IV.B.2.d. (2) (c)ii)e).

Here, the auditing

cardiologist determined that claimant's echocardiogram revealed
"many [echocardiographic] features of rheumatic mitral valve
disease:

1) leaflets thickening especially at the tip, with

diastolic doming[,]

2) chordal thickening, 3) restricted motion

of posterior mitral leaflet, 4) commissural fusion,

5) moderate

to severe mitral stenosis with mitral valve area of 1.6cm2."
The Technical Advisor also reviewed each of claimant's
echocardiograms and concluded that almost all of them
demonstrated a classic rheumatic mitral valve.

He explained,

for example, with respect to claimant's February 3, 2002
echocardiogram, that "[t]here was obvious doming of both
anterior and posterior mitral valve leaflets as well as
thickening of the tips of the leaflets" and that "[t]here was

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commissural fusion."

Dr. Vigilante made similar findings with

respect to claimant's echocardiograms of July 17, 2003,
April 21, 2004, April 12, 2008, September 24, 2009,
August 26, 2010, October 1, 2010, and June 11, 2011.
Dr. Vigilante even noted specific frames in many of the studies
that demonstrated the doming, thickening, and commissural fusion
that he observed. 13
Ms. Radandt did not adequately refute these findings.
Although she submitted a letter from Dr. Schapira, he only
stated that he reviewed claimant's echocardiograms of February
23, 2002, September 24, 2009, and August 26, 2010, and that
"these studies do not show evidence of a rheumatic valve disease
and I disagree with the conclusion of the auditor."
Claimant also does not dispute that there was evidence
of mitral valve and chordal thickening in her echocardiograms.
Instead, she argues that her "mitral valve disease was due to
her diet drug exposure" rather than a rheumatic mitral valve.
This argument is irrelevant.

Causation is not at issue in

resolving claims for Matrix Benefits.

Rather, claimants are

required to show that they meet, or in the case of the presence
13. We therefore reject claimant's argument that Dr.
Vigilante's use of the phrase "classic rheumatic mitral valve"
is a "broad-brush" term that claimant cannot "test or evaluate."
To the contrary, Dr. Vigilante identified at length the very
evidence of rheumatic mitral valve referred to in the Settlement
Agreement that he observed on Ms. Radandt's echocardiograms.

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of reduction factors, do not meet, the objective criteria set
forth in the Settlement Agreement.

As we previously concluded:

Class members do not have to
demonstrate that their injuries were caused
by ingestion of Pondimin and Redux in order
to recover Matrix Compensation Benefits.
Rather, the Matrices represent an objective
system of compensation whereby claimants
need only prove that they meet objective
criteria to determine which matrix is
applicable, which matrix level they qualify
for and the age at which that qualification
occurred.
Mem. in Supp. of Separate PTO No. 1415 at 51 (Aug. 28, 2000).
In addition, we noted:
[I]ndividual issues relating to
causation, injury and damage also disappear
because the settlement's objective criteria
provide for an objective scheme of
compensation.
Id. at 97.

If claimants are not required to demonstrate

causation, the converse is also true, namely, in applying the
terms of the Settlement Agreement, the Trust does not need to
establish that a reduction factor caused the medical condition
at issue.

The Settlement Agreement unequivocally requires a

mitral valve claim to be reduced to Matrix B if claimant's
echocardiogram reveals evidence of a rheumatic mitral valve 14 and

14. For this reason as well, we disagree with claimant that the
standard to be applied is whether one can diagnose rheumatic
mitral valve from an echocardiogram. The Settlement Agreement
plainly requires that a claim but be reduced if there is
"evidence" of a rheumatic mitral valve on a claimant's
(continued ... )
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a Board-Certified Pathologist has not provided a contrary
determination after examination of the mitral valve tissue.
must apply the Settlement Agreement as written.

We

Accordingly,

claimant's assertion that the cause of her mitral valve
condition was the ingestion of Diet Drugs is irrelevant to the
issue before the court.
Claimant's argument that she satisfied the
requirements of the Settlement Agreement because her pathologist
examined her mitral valve tissue and did not make a finding of
rheumatic mitral valve is erroneous.

We previously have held,

"Only upon a specific finding by a Board-Certified Pathologist
that the mitral valve tissue does not reveal evidence of
rheumatic valve disease may a claimant avoid application of the
reduction factor at issue."

Mem. in Supp. of Separate PTO

No. 9070 at 9 (May 21, 2013)

As a Board-Certified Pathologist

has not made a specific finding that Ms. Radandt's mitral valve
was not rheumatic, the Settlement Agreement requires that her
claim be reduced to Matrix B-1.
Finally, claimant's attempted reliance on her
representation that she was never diagnosed with rheumatic fever

( ... continued)
echocardiogram, "except where a Board-Certified Pathologist has
examined mitral valve tissue and determined that there was no
evidence of rheumatic valve disease." Settlement Agreement
§ IV. B. 2 . d. ( 2) ( c) ii) e) .

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also is misplaced.

Nothing in the Settlement Agreement provides

that evidence of the reduction factor of a rheumatic mitral
valve on a claimant's echocardiogram may be disregarded based on
an assertion that the claimant never was diagnosed or treated
for rheumatic fever.

We previously have held that a claimant

cannot meet his or her burden of proving the absence of
rheumatic mitral valve by reference to statements from a parent
and family physician to the effect that claimant never had
rheumatic fever.

See, e.g., Mem. in Supp. of Separate PTO

No. 7466, at 10 (Oct. 10, 2007).

As stated in the Settlement

Agreement, the qnly means by which a claimant may rebut
echocardiographic evidence of rheumatic valve disease is the
specific determination of a Board-Certified Pathologist.
Settlement Agreement

§

IV.B.2.d. (2) (c)ii)e).

See

Claimant has not

provided such a determination in this case.
For the foregoing reasons, we conclude that claimant
has not met her burden of proving that there is a reasonable
medical basis for her claim for Matrix A-1, Level IV benefits.
Therefore, we will affirm the Trust's denial of Ms. Radandt's
claim for supplemental Matrix Benefits.

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