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

Filing 4955

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9173 RE: CLAIMANT PAMELA C. TYLER. SIGNED BY HONORABLE HARVEY BARTLE, III ON 12/5/2013; 12/5/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110162 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.

Bartle, J.

qJ 73

December

5' ,

2013

Pamela C. Tyler ("Ms. Tyler" 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
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").
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, 2003, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Duncan
Salmon, M.D., F.A.C.C.

Based on an echocardiogram report dated

April 14, 2000, 3 Dr. Salmon attested in Part II of claimant's
Green Form that Ms. Tyler suffered from moderate mitral

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. The attesting physician relied on the report of claimant's
echocardiogram because claimant was unable to obtain a copy of
the echocardiogram tape.
See Settlement Agreement § VI.C.2.f.
The Trust did not contest that claimant had submitted the
affidavit required to rely on an echocardiogram no longer in
existence.
-2-

regurgitation, mitral valve prolapse, 4 mitral annular
calcification, 5 and an abnormal left atrial dimension. 6

Based on

such findings, claimant would be entitled to Matrix B-1, Level II
benefits in the amount of $108,673. 7
In the report of claimant's April 14, 2000
echocardiogram, the reviewing cardiologist, Rodney A. Johnson,
M.D., F.A.C.C., stated that claimant had "moderate mitral
insufficiency."

Dr. Johnson, however, did not specify a

percentage as to claimant's level of mitral regurgitation.

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%

4.
The presence of mitral valve prolapse requires the payment of
reduced Matrix Benefits for a claim based on damage to the mitral
valve.
See Settlement Agreement § IV.B.2.d. (2) (c)ii)b).
5. The presence of mitral annular calcification also requires
the payment of reduced Matrix Benefits for a claim based on
damage to the mitral valve.
See Settlement Agreement
§ IV. B . 2 . d . ( 2 ) ( c) ii) d) .
6. Dr. Salmon also attested that claimant suffered from moderate
aortic regurgitation, mitral annular calcification, and New York
Heart Association Functional Class I symptoms.
These conditions
are not at issue in this claim.
7. Under the Settlement Agreement, a claimant 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). Although the Trust
disputes that claimant had an abnormal left atrial dimension,
which is one of the complicating factors necessary for a Level II
claim, we need not resolve this issue given our determination
with respect to claimant's level of mitral regurgitation.
-3-

of the Left Atrial Area ("LAA").
§ I.

See Settlement Agreement

22.
In November, 2008, the Trust forwarded the claim for

review by M. Michele Penkala, M.D., one of its auditing
cardiologists.

In audit, Dr. Penkala determined that there was

no reasonable medical basis for Dr. Salmon's representation that
Ms. Tyler had moderate mitral regurgitation.

Dr. Penkala

explained:
To me the [mitral regurgitation] appears to
be trivial on the study dated 12/13/00 and
mild on the study dated 12/12/02.
I think it
is very unlikely that the [mitral
regurgitation] was truly moderate on the
[echocardiogram] study dated 4/14/00 (tape
not available) .
Based on the auditing cardiologist's findings,

the

Trust issued a post-audit determination denying Ms. Tyler's
claim.

Pursuant to the Rules for the Audit of Matrix

Compensation Claims ("Audit Rules"), claimant contested this
adverse determination. 8

In contest, Ms. Tyler argued that the

Settlement Agreement permits a claimant to seek Matrix Benefits
based solely on an echocardiogram report where, as Ms. Tyler has
done, a claimant submits the necessary affidavit that an
echocardiogram is no longer in existence.

Claimant further

8. 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 Pretrial
Order ("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. Tyler's claim.
-4-

asserted that the Trust violated the Settlement Agreement by
improperly denying her claim based on the auditing cardiologist's
review of her December 13, 2000 and December 12, 2002
echocardiograms. 9

Claimant also submitted a videotaped statement

under oath of Dr. Salmon, wherein he explained how he concluded
that claimant had moderate mitral regurgitation. 1 °

Finally,

claimant submitted an affidavit of Dr. Salmon, wherein he stated,
that:
I have authored a Green Form in the
claim of Pamela Tyler.
It is my conclusion,
to a reasonable degree of medical certainty,
that the April 14, 2000 echocardiogram
demonstrates conditions which entitle the
Claimant, Ms. Tyler, to Matrix Benefits from
the AHP Nationwide Settlement.
The basis for the qualifications for
Matrix Benefits in this specific claim is
based upon Ms. Tyler having moderate mitral
regurgitation concomitant with a left atrium
measurement of 4.1 [cm].
It is also
pertinent to note that she had moderate

9. Although claimant argued "no effort was made by the Trust or
auditing cardiologist to review other echocardiograms by the
first reviewing cardiologist, Rodney Johnson, M.D.," she did not
identify any other echocardiograms of Dr. Johnson that should
have been reviewed.
Ms. Tyler also asserted that the
echocardiograms used to support the denial of her claim were
"based upon a review, on third generation videotape, most likely
7-10 years old.
Further, the revolving [echocardiogram] review
is based upon different echocardiogram machines." The auditing
cardiologist and the Technical Advisor, however, were able to
review claimant's echocardiograms without any difficulty.
10. Claimant also submitted a June 17, 2003 letter from Evan
Selsky, M.D., F.A.C.C. Although claimant asserts this letter may
assist in explaining the change in her level of mitral
regurgitation from April 14, 2000 until her later
echocardiograms, Dr. Selsky only discusses claimant's aortic
insufficiency, which is not at issue in this claim.
-5-

aortic regurgitation. Ms. Tyler's claim is
reduced in value based upon the confounding
finding of mitral valve prolapse, and thus,
should be placed on Matrix B, Level II.
I have not reviewed the actual videotape
of this echocardiogram.
I am aware that the
videotape is irretrievably lost. My
conclusions are based upon the
echocardiography report of April 14, 2000
signed by Rodney A. Johnson, M.D.
I
personally know Dr. Johnson.
I am aware of
his qualifications and am proud to call him a
colleague.
I have reviewed other
echocardiogram reports and their videotapes
that were authored by Dr. Johnson and have
concurred with the findings of Dr. Johnson in
said echocardiograms.
I am aware that the AHP Settlement
requires using the Singh Criteria in
determining Matrix Benefits.
It is my
experience that the Singh Criteria regarding
mitral regurgitation is different than what
was typically used to determine moderate
mitral regurgitation in my general locality.
In other words, the ratio used in the Singh
Criteria for mitral regurgitation of a
moderate degree, typically required less
regurgitation for a moderate finding than
what was used on a common basis prior to the
AHP Settlement.
Reviewing a report from another
physician and accepting its conclusions are a
common occurrence in my everyday practice.
In treating my patients, I am required daily
to accept the findings of other competent
physicians in tests such as echocardiograms,
blood tests and other similar diagnostic
measures.
It is an accepted part of my
practice to rely upon tests and/or studies
performed by other physicians and/or
entities. Relying upon the findings of
Rodney A. Johnson, M.D. in this matter is not
a difficult task. Based upon my knowledge of
Dr. Johnson's expertise, I am confident
within a reasonable degree of medical
certainty that Ms. Tyler qualifies for Matrix

-6-

Benefits from the AHP Settlement as related
above. 11
Thus, according to claimant, "[t]he [t]otality of
[c] ircumstances" supports the payment of her claim. 12
Although not required to do so, the Trust forwarded the
claim for a second review by the auditing cardiologist.
Dr. Penkala submitted a declaration, in which she again concluded
that there was no reasonable medical basis for the attesting
physician's finding of moderate mitral regurgitation.

In her

declaration, Dr. Penkala stated, in relevant part, that:
11.

At Audit, I found that the 12/13/00
echocardiogram demonstrated trivial
(trace) mitral regurgitation. At
Contest, reviewed the 12/13/00 study in
its entirety and frame-by-by-frame
[sic] . I also reviewed the study at
those points identified by Dr. Salmon as
demonstrating moderate mitral
regurgitation.
I disagree with
Dr. Salmon's assessment that the mitral
regurgitation seen on this study is
moderate.
Several of the frames that
purportedly show[] blue color that
'almost fills the [left atrium]' appear
to be taken in early systole, and do not
depict true mitral regurgitation.
I
agree with Dr. Salmon that the mitral

11. Claimant also argues that, together with Dr. Salmon, "four
cardiologists disagree with Dr. Penkala's finding."
12.
In contest, claimant also submitted a number of other
materials related to the Trust's audits of Matrix claims, which
according to claimant, "raise concerns as to the auditing process
and echocardiogram reader variability." We disagree.
Claimant
makes no attempt to explain how these materials had any impact on
Dr. Penkala's review of her specific claim. As we consistently
have stated, the relevant inquiry is whether a claimant has
established a reasonable medical basis for his or her claim, an
inquiry that is to be made on a claim-by-claim basis.
See, e.g.,
Mem. in Supp. of PTO No. 6280, at 9 (May 19, 2006).
-7-

regurgitation present on this study is
eccentric and is better appreciated in
the parasternal long axis view, however
the mitral regurgitation appreciated in
the parasternal long axis view is, at
most, mild.
In the apical four-chamber
view, I found only a small jet of true
mitral regurgitation, which was
trace/trivial.

14.

I reexamined the study at Contest,
and I confirm my findings that mitral
regurgitation is mild . . . . I agree with
Dr. Salmon that the jet 'skirts the
posterior wall, 1 as it is definitely an
eccentric jet that might be missed in an
apical view. Mitral regurgitation
appears mild in the parasternal long
axis view.

17.

Dr. Salmon speaks of his reliance upon
the interpretation of the 4/14/00 study
by Dr. Rodney Johnson, and speaks very
highly of Dr. Johnson's accuracy and
reliability in [echocardiogram]
interpretation based on personal
experience. However, the 4/14/00
[echocardiogram] report which describes
moderate mitral regurgitation also
describes moderate mitral valve
prolapse, a condition which is not
evident on the 12/13/00 and 12/12/02
studies. That the 4/14/00 study
describes mitral valve prolapse (a
condition not known to improve over
time), which is not evident on either of
the available studies, raises concerns
about the accuracy and reliability of
the findings reported on the 4/14/00
[echocardiogram] report.

18.

Based upon my review of the ...
available 12/13/00 and 12/12/02 studies,
I do not believe that the 4/14/00
echocardiogram of attestation, if
available for review, would demonstrate
moderate mitral regurgitation ....
-8-

Accordingly, I affirm my findings at
audit, that there is no reasonable
medical basis for the Attesting
Physician's Green Form representations
that Claimant's 4/14/00 echocardiogram
study demonstrates moderate mitral
regurgitation .... 13
The Trust then issued a final post-audit determination
again denying Ms. Tyler's claim.

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 the claim should be paid.

On August 19, 2009, we

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

See PTO No. 8253

(Aug. 19, 2009).
Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
documentation.

Claimant advised the Special Master she would not

file a response, instead, relying on the material she submitted
in contest.

Under the Audit Rules, it is within the Special

Master's discretion to appoint a Technical Advisor 14 to review

13. As noted in the Report of Auditing Cardiologist Opinions
Concerning Green Form Questions at Issue, trace, trivial, or
physiologic regurgitation is defined as a 11 [n]on-sustained jet
immediately (within 1 cm) behind the annular place or <+ 5%
RJA/LAA. II
14. 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
(continued ... )
-9-

claims after the Trust and claimant have had their 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 had moderate mitral regurgitation.

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).
The Technical Advisor, Dr. Vigilante, reviewed
claimant's December 13, 2000 and December 12, 2002
echocardiograms and concluded that there was no reasonable basis

14.
( ... continued)
the critical technical problems." 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.
-10-

for the attesting physician's findings that claimant had moderate
mitral regurgitation.

Specifically, as to claimant's

December 13, 2000 echocardiogram, Dr. Vigilante explained:
Visually, only trace mitral regurgitation was
suggested in the parasternal long-axis and
apical views with a very eccentric jet
traveling slightly posteriorly with the left
atrium.
I digitized the cardiac cycles in
the apical four and two chamber views in
which the mitral regurgitant jet could best
be evaluated in the mid portion of systole. I
was able to accurately planimeter the mitral
regurgitant jet in the mid portion of
systole.
In the apical four chamber view,
the largest representative RJA was 0.9 cm2.
The LAA in the apical four chamber view was
18.2 cm2. Therefore, the largest
representative RJA/LAA ratio in the apical
four chamber view was 5% diagnostic of very
mild mitral regurgitation.
In the apical
four chamber view, the largest representative
RJA was 0.9 cm2. The LAA in the apical two
chamber view was 16.9 cm2. Therefore, the
largest representative RJA/LAA ratio in the
apical two chamber view was 5% diagnostic of
very mild mitral regurgitation.
As to claimant's December 12, 2002 echocardiogram,
Dr. Vigilante observed:
Visually, mild mitral regurgitation was
suggested in the apical views.
This
regurgitant jet was a posteriorly directed
jet into the left atrium.
I digitized the
cardiac cycles in the apical four and two
chamber views in which the mitral regurgitant
jet could best be evaluated.
In the apical
four chamber view, the largest representative
RJA was 1.9 cm2. The LAA in the apical four
chamber view was 18.2 cm2. Therefore, the
largest representative RJA/LAA ratio was 10%
qualifying for mild mitral regurgitation.
In
the apical two chamber view, the mitral
regurgitant jet was within 1 cm of the mitral
annulus classic for trace mitral
regurgitation.

-11-

Based on his review of claimant's echocardiograms,
Dr. Vigilante concluded that:
[T]here is no reasonable medical basis
for the Attesting Physician's answer to Green
Form Question C.3.a. That is, neither [of]
the reviewed echocardiographic studies came
close to demonstrating moderate mitral
regurgitation with comments as above. An
echocardiographer could not reasonably
conclude that moderate mitral regurgitation
was present on these studies even taking into
account the issue of inter-reader
variability.
It is also unlikely that the
April 14, 2000 echocardiogram would have
demonstrated moderate mitral regurgitation. 15
After reviewing the entire show cause record, we find
claimant's arguments are without merit.

As an initial matter,

claimant does not refute the specific conclusions of the auditing
cardiologist or the Technical Advisor that her December 13, 2000
echocardiogram and her December 12, 2002 echocardiogram reveal
neither moderate mitral regurgitation nor an abnormal left atrial
dimension. 16

In particular, the auditing cardiologist determined

15. Despite an opportunity to do so, claimant did not submit a
substantive response to the Technical Advisor Report. See Audit
Rule 34.
Instead, she requested another review of her claim
because the Special Master "previously had decided that Gary J.
Vigilante, M.D. would not be an Auditing Cardiologist in claims
where Dr. Mark Applefeld was the Attesting Cardiologist."
Dr. Applefeld was not the attesting physician or, it appears,
even involved, in Ms. Tyler's claim. Thus, we need not address
this issue.
See Mem. in Supp. of PTO No. 8510, at 10 n.11
(July 29, 2010).
16. The report for claimant's December 12, 2002 echocardiogram
specifically states that claimant has only mild mitral
regurgitation.
Further, the videotaped testimony of the
attesting physician taken by claimant's counsel also is not
definitive. Dr. Salmon states that the level of claimant's
(continued ... )
-12-

that claimant's December 13, 2000 echocardiogram demonstrated
only trivial mitral regurgitation and her December 12, 2002
echocardiogram demonstrated mild mitral regurgitation.
Similarly, the Technical Advisor concluded that claimant's
December 13, 2000 echocardiogram demonstrated "very mild mitral
regurgitation" and her December 12, 2002 echocardiogram
demonstrated mild mitral regurgitation.
Instead, claimant argues that the Trust could not rely
on Ms. Tyler's later echocardiograms in determining whether there
was a reasonable medical basis for the attesting physician's
representation of moderate mitral regurgitation.

In support of

this argument, claimant relies on § VI.C.l.c. of the Settlement
Agreement:
A Diet Drug Recipient who demonstrates to the
Trustees and/or Claims Administrator(s) that
he or she had an Echocardiogram conducted
between September 30, 1999, and the date of
commencement of Class Notice which a
Qualified Physician reported as showing that
he or she had FDA Positive regurgitation
shall not be disqualified from receiving
settlement benefits if the Echocardiogram
does not meet all of the requirements of
Section VI. C. 1. b. above. 17

16.
( ... continued)
mitral regurgitation on her December 13, 2000 echocardiogram is
"at least mild" and "possibly moderate in some views." Thus,
claimant's assertion that four cardiologists disagree with the
auditing cardiologist as to the level of claimant's mitral
regurgitation is inaccurate.
17. Section IV.C.1.b. of the Settlement Agreement sets forth
certain requirement regarding echocardiograms performed after
September 30, 1999.
-13-

Contrary to claimant's argument, nothing in this
provision requires the payment of Ms. Tyler's claim for Matrix
Benefits.

The claimant is correct in noting that the Settlement

Agreement, upon the satisfaction of certain conditions, allows a
claimant to rely on the results of an echocardiogram when the
echocardiogram itself can no longer be located.
Agreement

§§

VI.C.2.e. and f.

See Settlement

However, nothing in the Settlement

Agreement requires the Trust simply to accept the findings stated
in an echocardiogram report where the echocardiogram tape is no
longer in existence.
Further, claimant's argument ignores

§

VI.E.6. of the

Settlement Agreement, which states:
In conducting an audit of those Claims and
Requests for Credit selected for audit, the
Trustees and/or Claims Administrator(s) shall
follow the following procedure: All
Accelerated Implementation Option acceptance
form ( s) ("PINK FORM") , registration form ( s)
("BLUE FORM"), videotapes or disks of
Echocardiograms, medical reports, and other
information submitted by AHP in support of a
Request for Credit or by a Class Member in
support of a Claim, together with a copy of
the claimant's medical records, and
Echocardiogram videotapes or disks obtained
by the Trustees/Claims Administrator(s) shall
be forwarded to a highly-qualified,
independent, Board-Certified Cardiologist
(hereinafter referred to as the "Auditing
Cardiologist") selected by the Trustees/
Claims Administrator(s). After thoroughly
reviewing these materials, the Auditing
Cardiologist shall make a determination as to
whether or not there was a reasonable medical
basis for the representations made by any
physician in support of the Claim or Request
for Credit.

-14-

Id. § VI.E.6.; see also Audit Rule 7(a).

Accepting claimant's

interpretation would effectively negate this provision of the
Settlement Agreement.
Claimant's interpretation also is not supported by the
parties responsible for drafting the Settlement Agreement,
namely, Class Counsel and Wyeth.

In October, 2010, we requested

the views of Wyeth and Class Counsel as to the parties' intention
with respect to

§

VI.C.4.b. and

Settlement Agreement.

§§

VI.C.2.e. and f. of the

See PTO No. 8579 (Oct. 18, 2010).

In a

joint response, Class Counsel and Wyeth stated their position as
follows:
Where the tape or disk of the Qualifying
Echocardiogram, the echocardiogram that
supports the presence of a Matrix Level
condition and/or the echocardiogram that
supports the presence or absence of a
Reduction Factor no longer exists or cannot
be found, the Class Member must submit a
sworn affidavit from the last custodian of
the tape or disk documenting that such tape
or disk no longer exists and explaining to
the satisfaction of the Trust the
circumstances under which the tape or disk
"came to be misplaced or destroyed."
If the Class Member makes that showing,
the Trust may rely upon other medical
evidence regarding the presence or absence of
the regurgitation diagnosed by the Qualifying
Echocardiogram, the presence or absence of a
Matrix Level condition, and the presence or
absence of a Reduction Factor, including the
written [echocardiogram] report of the
missing tape or disk prepared when the
echocardiogram was conducted and all other
Medical Information submitted on the claim,
such as hospital records, results of cardiac
catheterizations, surgical reports, pathology
reports, and any other echocardiogram
studies. The Auditing Cardiologist shall
-15-

weigh all such Medical Information and the
totality of the medical facts presented in
evaluating whether there is a reasonable
medical basis for the level of regurgitation
on the Qualifying Echocardiogram, the
presence of a Matrix Level condition and the
absence of pertinent reduction factors as
asserted by the Attesting Physician in the
Green Form submitted by the Class Member in
support of the Class Member's Matrix claim.
(emphasis added.)
This is precisely what occurred here.

The claimant was

permitted to proceed with her claim upon submission of the
required documentation to establish that her April 14, 2000
echocardiogram was no longer in existence.

The auditing

cardiologist and Technical Advisor equally were permitted to
consider, among other things, claimant's December 13, 2000 and
December 12, 2002 echocardiograms in determining whether there
was a reasonable medical basis for the attesting physician's
representations.

As a review of those materials revealed that

the attesting physician's representations lacked a reasonable
medical basis, the Trust properly denied claimant's request for
Level II Matrix Benefits.
Claimant's reliance on

§

Agreement is similarly misplaced.

VI.C.1.d. of the Settlement
This provision of the

Settlement Agreement states:
A claimant who qualifies for a particular
Matrix payment, by virtue of a properly
interpreted Echocardiogram showing the
required levels of regurgitation and/or
complicating factors, after exposure to
fenfluramine and/or dexfenfluramine, shall
not be disqualified from receiving that
Matrix payment in the event that a subsequent
-16-

Echocardiogram shows that the required levels
of regurgitation and/or complicating factors
are no longer present.
Settlement Agreement

§

VI.C.1.d.

argument, claimant had not yet
Matrix payment."

11

Contrary to Ms. Tyler's
qualifie[d]

for a particular

In particular, we disagree with claimant that

the echocardiogram report of her April 14, 2000 echocardiogram
established a reasonable medical basis for her claim that she was
qualified to receive Level II Matrix Benefits under the
Settlement Agreement.
Finally, to the extent claimant argues that
inter-reader variability accounts for the difference in the
opinions of the attesting physician, the Technical Advisor and
the auditing cardiologist, such argument is misplaced.

The

concept of inter-reader variability is already encompassed in the
reasonable medical basis standard applicable to claims under the
Settlement Agreement.

In this instance, the opinions of

claimant's cardiologists cannot be medically reasonable where the
auditing cardiologist and Technical Advisor concluded, and
claimant did not adequately dispute, that Ms. Tyler did not have
moderate mitral regurgitation. 18

To conclude otherwise would

allow a claimant to receive Matrix Benefits when his or her level
of mitral regurgitation is below the threshold established by the

18. For this reason as well, we reject claimant's assertion that
her claim should be paid because Dr. Johnson was in the best
position to determine Ms. Tyler's level of mitral regurgitation.
-17-

Settlement Agreement.

This result would render meaningless the

standards established in the Settlement Agreement.
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 had moderate mitral
regurgitation.

Therefore, we will affirm the Trust's denial of

Ms. Tyler's claim for Matrix Benefits.

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