BROWN, et al v. AMERICAN HOME PROD, et al
Filing
4877
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9133 RE: CLAIMANT BETHANY MASSEY. SIGNED BY HONORABLE HARVEY BARTLE, III ON 8/20/2013; 8/20/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110094 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
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.
q133
August J.O, 2013
Bartle, J.
Bethany Massey ("Ms. Massey" or "claimant"), a class
member under the Diet Drug Nationwide Class Action Settlement
Agreement ("Settlement Agreement") with Wyeth, 1 seeks benefits
from the AHP Settlement Trust ("Trust").
Based on 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 tnat 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
(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 April, 2008, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Gary L.
Murray, M.D.
Based on an echocardiogram dated February 18, 1999,
Dr. Murray attested in Part II of Ms. Massey's Green Form that
she suffered from moderate mitral regurgitation and had surgery
to repair or replace the aortic and/or mitral valve(s) following
the use of Pondimin® and/ or Redux TM. 3
Based on such findings,
2.
( ... continued)
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. Dr. Murray also attested that clai~ant suffered from a
reduced ejection fraction in the range !of 50% to 60%. This
condition is not at issue in this claim.
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claimant would be entitled to Matrix A-1, Level III benefits in
the amount of $879,943. 4
Dr. Murray also attested that claimant did not have a
rheumatic mitral valve.
Under the Settlement Agreement, the
presence of a rheumatic mitral valve requires the payment of
reduced Matrix Benefits.
§
IV.B.2.d. (2) (c)ii)e).
See Settlement Agreement
Evidence of a rheumatic valve is defined
by the Settlement Agreement as "doming of the anterior leaflet
and/or anterior motion of the posterior leaflet and/or
commissural fusion."
See id.
As the Trust does not contest
claimant's entitlement to Level III Matrix Benefits, the only
issue before us is whether claimant is entitled to payment on
Matrix A-1 or Matrix B-1.
In June, 2008, the Trust forwarded the claim for review
by Craig M. Oliner, M.D., one of its auditing cardiologists. 5
In
audit, Dr. Oliner concluded that there was no reasonable medical
basis for Dr. Murray's finding that claimant did not have a
rheumatic mitral valve.
Specifically, Dr. Oliner stated:
There is definite anterior leaflet diastolic
mild doming, consistent with rheumatic mitral
4. Under the Settlement Agreement, a claimant is entitled to
Level III benefits if he or she suffers from "left sided valvular
heart disease requiring ... [s]urgery to repair or replace the
aortic and/or mitral valve(s) following the use of Pondimin®
and/or Redux™." See Settlement Agreement § IV.B.2.c. (3) (a).
5.
Pursuant to Pretrial Order ("PTO") No. 3882 (Aug. 24, 2004),
all Level III, Level IV, and Level V M~trix claims were subject
to the Parallel Processing Procedures (i"PPP") . As Wyeth did not
agree that claimant had a Matrix A-1, ~evel III claim, pursuant
to the PPP, the Trust audited Ms. Massey's claim.
-3-
valve disease. Both leaflet tips are
thickened, consistent with rheumatic mitral
valve disease. There is submitral apparatus
involvement. The surgical report states the
intraoperative [transesophageal
echocardiogram] confirmed a rheumatic looking
valve. At surgery, the mitral valve was
found to be scarred, with the anterior
leaflet pulled inward and the papillary heads
fused to the back of the valve. The
[transesophageal echocardiogram] report from
10/5/01 states the mitral valve was rheumatic
in morphology.
Based on Dr. Oliner's finding,
the Trust issued a
post-audit determination that Ms. Massey was entitled only to
Matrix B-1, Level III benefits.
Pursuant to the Rules for the
Audit of Matrix Compensation Claims ( 11 Audit Rules 11 ) , claimant
contested this adverse determination. 6
In contest, claimant
argued that her February 18, 1999 echocardiogram did not
demonstrate a rheumatic mitral valve and that the other materials
submitted with her claim, including an October 5, 2001
echocardiogram, an October 5, 2001 operative report, and an
October 6, 2001 pathology report did not establish that Ms.
Massey had rheumatic mitral valve disease at the time of her
mitral valve replacement surgery.
In support, claimant submitted
a verified statement of Manoj R. Muttreja, M.D.
Dr. Muttreja
stated, in pertinent part, that:
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 1 as approved in PTO
No. 2457 (May 31, 2002). Claims place4 into audit after
December 1, 2002 are governed by the A~dit 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. Massey's claim.
-4-
In his Report of Auditing Cardiologist
Opinion Concerning Green Form Questions at
Issue, Dr. Oliner stated, "There is definite
anterior leaflet diastolic mild doming,
consistent with rheumatic mitral valve
disease." Presumably this observation
pertains to the 02/18/1999 [transthoracic
echocardiogram]. As an initial matter, this
statement is inconsistent in its conflation
of "mild" and "definite." The interpreting
cardiologist of this study did not mention
these findings or come up with the overall
conclusion that Ms. Massey had the findings
of a rheumatic valve in his report of this
study.
In my review of the videotape, I saw
perhaps only mild doming in some off-axis
views.
The mild doming was inconsistent
throughout the study and did not appear in
any standard views and, in my opinion, was
certainly not consistent with the findings of
a rheumatic valve. Moreover, this
echocardiogram contained additional views
during the stress component. No doming or
restriction of the anterior leaflet
(hockey-sticking) occurred during these
additional stress images of the
echocardiogram when the patient reached her
peak goal heart rate. This finding would
definitely be present and blatantly obvious
if Ms. Massey truly had a rheumatic mitral
valve. Dr. Oliner also noted that "both
leaflet tips are thickened, consistent with
rheumatic mitral valve disease." However,
leaflet tip thickening is not a finding
specific to rheumatic heart disease and is
present in multiple different pathologies.
Dr. Oliner also referenced the surgical
report and intraoperative [transesophageal
echocardiogram] in his report.
First, I
would like to point out that a rheumatic
heart valve cannot be diagnosed by the
surgeon. A surgeon can only see the gross
view of the valve during his operation. The
gross findings of a rheumatic valve are very
nonspecific and can be seen in multiple
different pathologies. Such a diagnosis can
be suggested by echocardiography and
definitely made by pathology .I The report of
the 10/05/2001 intraoperative
[transesophageal echocardiog~am] while indeed
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stating that the mitral valve appears
"rheumatic in morphology" also states that
posterior leaflet is fixed but the anterior
leaflet opening appears normal. Again, one
would see restricted motion of the anterior
leaflet in the case of a rheumatic mitral
valve and not just the involvement of a
portion of the valve. The surgeon found the
valve to be scarred with the anterior leaflet
pulled inward and the papillary heads fused
to the back of the valve. Such findings are
not specific to rheumatic mitral valve, and
could, in fact, be more indicative of lesions
induced through fenfluramine exposure.
I
have seen multiple valves like the one
described by this surgeon in my experience
that have been caused by fenfluramine
exposure and not rheumatic heart disease.
Interestingly, Dr. Oliner appears to
have completely disregarded the 09/07/2001
[transesophageal echocardiogram] and the
surgical pathology report.
I have reviewed
the videotape of the 09/07/2001
[transesophageal echocardiogram] . Although
the report of the [transesophageal
echocardiogram] states the mitral valve
appears to be normal, the valve appears
thickened and there is some restriction of
the posterior leaflet. However, there is no
heavy calcification or doming which would be
present in the case of a rheumatic mitral
valve.
Most importantly, the surgical pathology
report contains no indication whatsoever that
her excised mitral valve was rheumatic. The
pathologist's diagnosis is "atherosclerosis,
calcification and myoxid degeneration." Her
findings are not consistent with a diagnosis
of rheumatic mitral valve disease. Rheumatic
valve disease would have been mentioned as a
matter of course had it been indicated by the
pathologist's findings.
In summary, it is my opinion from the
review of the materials provided, that
Ms. Massey did not have a rheumatic mitral
valve before the mitral valv~ replacement.
Dr. Oliner's finding that she exhibited a
rheumatic valve appears to have been based
-6-
primarily on the surgeon's comments rather
than pathological evidence and evidence from
the echocardiograms.
Although not required to do so, the Trust forwarded the
claim for a second review by the auditing cardiologist.
Dr. Oliner submitted a declaration again concluding that there
was no reasonable medical basis for the attesting physician's
determination that there was no evidence of a rheumatic mitral
valve.
Dr. Oliner explained:
11.
During my review of this Claim at audit,
I stated that the February 18, 1999
echocardiogram demonstrates anterior
leaflet diastolic mild doming and
thickening of both leaflet tips,
consistent with rheumatic mitral valve
disease. Upon review of the
February 18, 1999 echocardiogram study
at Contest, I again observed definite
mild diastolic doming in the parasternal
long axis view, which is a standard
view.
The diastolic doming is both
definite and mild. These findings are
consistent with rheumatic disease and
support a diagnosis of rheumatic mitral
valve disease.
12.
At Contest, I also reviewed the
September 7, 2001 [transesophageal
echocardiogram] study. This study shows
thickened and partially calcified mitral
leaflets with mild diastolic doming and
chordal shortening. These findings are
suggestive of rheumatic mitral valve
disease.
13.
In addition to echocardiographic
evidence of rheumatic mitral valve
disease, Claimant's medical records
support a diagnosis [of] rheumatic
mitral valve disease. The
October 5, 2001 [transesophageal
echocardiogram] report ~tates the mitral
valve "appears rheumatid in morphology,"
and the October 5, 2001 !operative report
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states that, on direct visualization,
the mitral valve appeared rheumatic in
morphology.
Further, the
October 8, 2001 surgical pathology
report states that the mitral valve was
"mildly thickened and fibrotic", with
"focal slight thickening and fusion of
the chordae tendinae." Microscopic
findings were "focal calcification,
atherosclerosis and myoxid
degeneration." While the surgical
pathology report does not expressly
identify rheumatic valve disease, the
surgical pathologic findings are
consistent with rheumatic mitral valve
disease.
The Trust then issued a final post-audit determination,
again determining that Ms. Massey was entitled only to
Matrix B-1, Level III 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. Massey's claim should be paid.
On
June 4, 2009, we issued an Order to show cause and referred the
matter to the Special Master for further proceedings.
See PTO
No. 8182 {June 4, 2009).
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 August 26, 2009.
Under
the Audit Rules, it is within the Special Master's discretion to
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appoint a Technical Advisor 7 to review claims after the Trust 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., 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 issue presented for resolution of this claim is
whether claimant has met her burden of proving that there is a
reasonable medical basis for the attesting physician's finding
that she did not have a rheumatic mitral valve.
See id. Rule 24.
Ultimately, if we determine that there is no reasonable medical
basis for the answer in claimant's Green Form that is at issue,
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 answer, we must enter an Order directing the Trust
to pay the claim in accordance with the Settlement Agreement.
See id. Rule 38(b).
7. 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 s~ch 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.
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In support of her claim, Ms. Massey reasserts the
arguments she made in contest.
In response, the Trust argues
that Dr. Oliner properly determined that there was
echocardiographic evidence of rheumatic mitral valve on
claimant's various echocardiograms.
In addition, the Trust
contends that Ms. Massey cannot overcome the echocardiographic
evidence of rheumatic mitral valve by reference to a nonspecific
pathology report.
The Technical Advisor, Dr. Vigilante, reviewed
Ms. Massey's claim and concluded that there was no reasonable
medical basis for the attesting physician's finding.
Specifically, Dr. Vigilante observed:
I reviewed the Claimant's echocardiogram of
February 18, 2009. This was both a resting
and stress study .... This was a good quality
study with the usual echocardiographic views
obtained.
I reviewed all images of the
mitral valve and mitral apparatus in realtime and I digitized these images and
reviewed them in multiple loops. Both mitral
leaflets were moderately thickened. There
was increased refractoriness of echoes at the
tips of both leaflets consistent with focal
calcification of the mitral valve leaflet
tips.
There was classic doming of the
anterior mitral leaflet seen in the
parasternal, apical four chamber and apical
two chamber views. Significant mitral
stenosis was not present. The motion of the
anterior mitral leaflet had a "hockey stick"
appearance. Doming and the "hockey stick"
appearance of the anterior mitral leaflet
were due to commissural fusion.
The belly of
the anterior leaflet was more pliable and
moved further out than the leaflet tip
causing this abnormal motion.
There was
significant thickening of th~ mitral cords
particularly those cords that were attached
to the mid portion of the anterior mitral
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leaflet. These echocardiographic findings
are classic for rheumatic involvement of the
mitral valve seen in the parasternal long
axis view, apical four chamber and apical two
chamber views. The findings at the time of
cardiac surgery by Dr. Petracek on October 5,
2001 that included a scarred down mitral
valve as well as papillary muscle head fusion
to the back of the valve are also classically
seen in rheumatic mitral valvular disease ....
I also reviewed the Claimant's
transesophageal echocardiogram of
September 7, 2001 .... This was a reasonable
quality study with the usual [transesophageal
echocardiogram] views obtained.
I reviewed
all images of the mitral valve and mitral
apparatus in real-time and digitized these
images and reviewed them in multiple loops.
Once again, it was noted that both mitral
leaflets were moderately thickened and there
was classic doming of an anterior mitral
leaflet seen particularly at 25 degrees,
141 degrees, and 146 degrees. The belly of
the mitral leaflet was more pliable and moved
further out than the leaflet tip causing this
abnormal doming motion. This abnormal motion
was caused because of commissural fusion.
There was focal calcification at the tips of
the mitral leaflets. Subvalvular chordal
thickening and fusion were noted ....
After analyzing both echocardiogram tapes and
reviewing the medical records, I reviewed
Dr. Muttreja's letter of February 19, 2009.
This cardiologist was incorrect in stating
that there was only mild doming in some
off-axis views and that the mild doming was
inconsistent throughout the study.
Indeed,
doming was obvious in multiple views.
I also
disagree with Dr. Muttreja's statement that
the pathologist would have mentioned
rheumatic valve disease upon .examination of
the tissue. Based on my review of the
echocardiograms and accompanying medical
records, it would be impossible for a
reasonable echocardiographer ito conclude that
the mitral valve was not a s~ructurally
rheumatic valve.
-11-
In response to the Technical Advisor Report, claimant
argues that Dr. Muttreja's findings were correct and supported by
the auditing cardiologist, who found only mild doming on the
February 18, 2009 echocardiogram.
Ms. Massey also contends
Dr. Vigilante erred because he did not address Dr. Muttreja's
opinion that doming or restriction of the anterior leaflet would
have appeared in the stress portion of her echocardiogram if she
had rheumatic mitral valve.
In addition, Ms. Massey asserts that
the surgical findings do not support a finding of rheumatic
mitral valve because, as Dr. Muttreja explained, these findings
"could very well be consistent with other disease processes
caused by fenfluramine exposure."
Finally, claimant argues that
Dr. Vigilante inappropriately dismissed the absence of a
rheumatic mitral valve finding in the pathology report.
After reviewing the entire Show Cause Record, we find
claimant's arguments are without merit.
The Settlement Agreement
specifically provides, in pertinent part, that a claimant will
receive reduced Matrix Benefits if there is:
M-Mode and 2-D echocardiographic evidence of
rheumatic mitral valves (doming of the
anterior leaflet 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)
(emphasis added).
Here, the auditing cardiologist determined, and claimant does not
adequately contest, that her echocardiograms reveal evidence of a
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rheumatic mitral valve.
In particular, Dr. Muttreja noted, "In
my review of the [February 18, 1999] videotape, I saw perhaps
only mild doming in some off-axis views."
He also stated,
"Although the report of the [September 7, 2001 echocardiogram]
states the mitral valve appears to be normal, the valve appears
thickened and there is some restriction of the posterior
leaflet."
Similarly, Dr. Oliner determined that claimant's
February 18, 1999 transthoracic echocardiogram demonstrates
"definite mild diastolic doming in the parasternal long axis
view" and that claimant's September 7, 2001 echocardiogram "shows
thickened and partially calcified mitral leaflets with mild
diastolic doming and chordal shortening."
The Technical Advisor
also reviewed claimant's February 18, 1999 and September 7, 2001
echocardiograms and concluded that each demonstrated classic
doming of the anterior leaflet and commissural fusion.
To meet her burden, claimant notes that the surgical
pathology report does not contain any indication that her mitral
valve was rheumatic.
In addition, she relies on Dr. Muttreja•s
opinion the echocardiographic characteristics demonstrated on her
echocardiograms are not consistent with a finding of rheumatic
mitral valve.
Thus, according to claimant, there is a reasonable
medical basis for the attesting physician's conclusion that
Ms. Massey did not have a rheumatic mitral valve.
Claimant's
reliance on the pathology report and Dr. Muttreja's opinion,
however, are misplaced.
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Under the Settlement Agreement, if there is
echocardiographic evidence of rheumatic valve disease, a claim
will be reduced to the B-1 Matrix, except where a Board-Certified
Pathologist examines the mitral valve tissue and determines that
there is no evidence of rheumatic valve disease.
Agreement
§
IV.B.2.d. (2) (c)ii)e).
See Settlement
As noted, Dr. Muttreja
concedes that claimant's echocardiograms contain evidence, as
defined by the Settlement Agreement, of a rheumatic mitral valve.
Although claimant asserts that the absence of any reference to
rheumatic valve disease in her pathology report supports her
claim, the opposite is true.
Only a specific finding by a
Board-Certified Pathologist that the mitral valve tissue does not
reveal evidence of rheumatic valve disease will allow a claimant
to avoid application of this reduction factor.
See, e.g., Mem.
in Supp. of PTO No. 7466 at 9 (Oct. 10, 2007);
Mem. in Supp. of
PTO No. 7467 at 6-7 (Oct. 10, 2007).
Finally, we reject claimant's argument that she is
entitled to Matrix A-1 benefits because the condition of her
mitral valve is more consistent with exposure to Diet Drugs than
rheumatic valve disease.
Causation is not at issue in resolving
claims for Matrix Benefits.
Rather, claimant is required to show
that she meets, or in the case of the presence of reduction
factors, does 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
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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 ....
PTO No. 1415 at 51 (Aug. 28, 2000).
In addition, we noted that:
[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.
As the Settlement Agreement unequivocally requires a
mitral valve claim to be reduced to Matrix B-1 if claimant's
echocardiogram reveals evidence of a rheumatic mitral valve and a
Board-Certified Pathologist has not provided a contrary
determination after examination of the mitral valve tissue, we
must apply the Settlement Agreement as written.
Accordingly,
claimant's assertion that the condition of her mitral valve was
caused by her ingestion of Diet Drugs is irrelevant to the issue
before the court.
Because claimant does not adequately contest
that her echocardiograms revealed evidence of a rheumatic mitral
valve and a Board-Certified Pathologist has not provided a
contrary determination, the Settlement Agreement requires that
Ms. Massey's claim be reduced to Matrix B-1.
-15-
For the foregoing reasons, we conclude that claimant
has not met her burden of proving that there is a reasonable
medical basis for finding that she did not have a rheumatic
mitral valve.
Therefore, we will affirm the Trust's denial of
Ms. Massey's claim for Matrix A-1 benefits.
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