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

Filing 4941

MEMORANDUM IN SUPPPORT OF SEAPARATE PRETRIAL ORDER NO. 9164 RE: CLAIMANT TONYA R. MARLER. SIGNED BY HONORABLE HARVEY BARTLE, III ON 11/19/2013; 11/20/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110145 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.

November

I (o
J ~,

2013

Tonya R. Marler ("Ms. Marler" 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")
and, if so, whether she met her burden of proving that her claim
was not based, in whole or in part, on any intentional material
misrepresentation of fact.

2

1.
Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
In 2009, Pfizer, Inc. acquired Wyeth.
2. Matrix Benefits are paid according to two benefit matrices
(Matrix "A" and Matrix "B"), which generally classify claimants
(continued ... )

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

The Green Form consists of

The claimant or the claimant's representative

completes Part I of the Green Form.

Part II is completed by the

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

Finally, claimant's attorney completes Part III if

claimant is represented.
In July, 2002, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Howard L.
Brazil, M.D., F.A.C.C.

Based on an echocardiogram dated

June 14, 2002, Dr. Brazil attested in Part II of claimant's Green
Form that Ms. Marler suffered from moderate mitral regurgitation
and a reduced ejection fraction in the range of 50% to 60%.

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

Based on such findings, claimant would be entitled to Matrix A-1,
Level II benefits in the amount of $641,205. 3
In the report of claimant's echocardiogram, Dr. Brazil
stated that Ms. Marler had "moderate regurgitation with a
regurgitant jet to left atrial area of 28%."

Under the

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

I.22.

See Settlement Agreement

Dr. Brazil also stated that there was an "ejection

fraction of 55%."

An ejection fraction is considered reduced for

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

See id.

§

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

In December, 2003, the Trust forwarded the claim for
review by Richard Stagl, M.D., F.A.C.C., one of its auditing
cardiologists.

In audit, Dr. Stagl determined that there was a

reasonable medical basis for Dr. Brazil's findings of moderate
mitral regurgitation and a reduced ejection fraction.
Before the Trust issued a determination based on this
review, we imposed a stay on the processing of claims pending
implementation of the Seventh Amendment to the Settlement

3. Under the Settlement Agreement, an eligible class member is
entitled to Level II benefits for damage to the mitral valve if
he or she is diagnosed with moderate or severe mitral
regurgitation and one of five complicating factors delineated in
the Settlement Agreement.
See Settlement Agreement
§ IV.B.2.c. (2) (b).
A reduced ejection fraction is one of the
complicating factors necessary for a Level II claim.
-3-

Agreement.

After the stay was lifted, we entered Pretrial Order

("PTO") No. 5632, which provided certain claimants, including
Ms. Marler, with the option either to undergo a re-audit of their
claims or to elect to stand on the results of their prior audit
and proceed pursuant to the Rules for the Audit of Matrix
Compensation Claims ("Audit Rules").

Ms. Marler elected not to

undergo a re-audit of her claim.
Prior to the Trust's processing of her claim pursuant
to the Audit Rules, however, this court approved Court Approved
Procedure ( 11 CAP 11 ) No. 13, which provided certain claimants,
including Ms. Marler, with the option either to submit their
claims to a binding medical review by a participating physician
or to opt-out of CAP No. 13 and proceed pursuant to the Audit
Rules.

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

Ms. Marler elected to

opt-out of CAP No. 13.
Thus, pursuant to Rule 5 of the Audit Rules, the Trust
undertook "to determine whether there were any intentional
material misrepresentations made in connection with the Claim."
As part of this review, the Trust engaged Joseph Kisslo, M.D., to
review the integrity of the echocardiogram system used during the
performance of echocardiographic studies and the resulting
interpretations submitted in support of certain claims.

As

stated in his March 1, 2007 declaration, Dr. Kisslo determined,
in pertinent part, that:
In Ms. Marler•s study, the use of high color
gain and a decreased Nyquist setting, the
selection and planimetry of backflow, and the
-4-

overmeasurement of the mitral "jet," as well
as the undermeasurement of the left atrial
area are the result of deliberate choices and
conduct engaged in by the sonographer
performing this study and at a minimum,
acquiesced in by the Attesting Physician.
Each of these manipulations exaggerated or
created the appearance of regurgitation or
jet duration. Ms. Marler only has mild
mitral regurgitation--not moderate mitral
regurgitation as claimed by the Attesting
Physician.
There is no reasonable medical
basis for a finding of moderate mitral
regurgitation based on this study.
Accordingly, notwithstanding Dr. Stagl's findings at
audit, the Trust issued a post-audit determination denying
Ms. Marler's claim based on its conclusion that there was
substantial evidence of intentional material misrepresentation of
fact in connection with the claim.

Pursuant to the Audit Rules,

Ms. Marler contested this adverse determination. 4

In contest,

claimant argued that her echocardiogram was performed in a manner
consistent with the standards set forth in the Settlement
Agreement.

In support, claimant submitted affidavits from

Dr. Brazil; Lynda F. Lollar-Goldstein, the Registered
Cardiovascular Technologist who performed Ms. Marler's
echocardiogram; and Gerald L. Fitzgerald, Sr., the owner of the
company that performed Ms. Marler's echocardiogram.

In his

affidavit, Dr. Brazil stated, in pertinent part, that:

4.
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. Marler's claim.
-5-

10. Contrary to Paragraph 7 of
Dr. Kisslo's declaration, I did not see
excessive gain, color pixel dominance and the
presence of color persistence or marked
errors in the selection and measurement of
jets and structures which would alter my
original conclusions. Any errors made by the
echocardiogram technician in tracing were
slight and did not impact the ultimate
diagnosis.
11. And, contrary to Dr. Kisslo's
finding, I did not find evidence of a
concomitant use of decreased Nyquist settings
or an exaggerated appearance of regurgitation
and/or complicating factors.
By Dr. Kisslo's
own admission, the Nyquist setting in this
instance was within the acceptable range (See
Figure 5 on page 8 of Dr. Kisslo's
declaration) .
12.
I agree with Dr. Kisslo's statement
that, "[s]ome of the hard controls, in
particular color gain, image gain, and sector
depth are adjusted to reflect the variability
in patient physiology and attenuation as well
as machine sensitivity normally encountered
in imaging." My review of Ms. Marler's video
tape and [magneto optical] disk indicates
that the [sonographer] made adjustments
during the course of the procedure to
optimize the picture, not manipulate or
materially misrepresent the injury sustained
by Ms. Marler.
Such adjustments are common
in the ordinary course of conducting
echocardiograms and I cannot see any evidence
of any intentional material misrepresentation
of fact as Dr. Kisslo and his staff suggest.
In her affidavit, Ms. Lollar-Goldstein stated she was familiar
with the Settlement Agreement criteria and that each
echocardiogram she performed was in accordance with that protocol
and to the best of her ability.

In addition, she noted that any

adjustment she made to the echocardiogram machine settings during
an echocardiogram "was done to optimize the image for the benefit

-6-

of the doctor reading the procedure, not for the purpose of
creating the false impression that an injury exists."

Finally,

Ms. Lollar-Goldstein stated that "virtually all echocardiograms
will show some evidence of sparkling or excessive color gain if
each frame is analyzed during the time the technician is making
adjustments and attempting to optimize an image."

In his

affidavit, Mr. Fitzgerald stated that he always instructed his
technicians to apply the Settlement Agreement criteria.
Claimant also argued that her echocardiogram
demonstrated moderate mitral regurgitation.

In his declaration,

Dr. Brazil stated that he had reviewed claimant's echocardiogram
and concluded that it "demonstrates that her regurgitant jet area
is 28%, well within the moderate range .... "

In addition,

Ms. Marler noted that Dr. Brazil participated in the Trust's
Screening Program. 5
The Trust then issued a final post-audit determination,
again denying Ms. Marler's claim.

The Trust argued that

claimant's contest failed to address adequately Dr. Kisslo's
findings of mismeasurements.

The Trust also asserted that

Dr. Brazil did not expressly deny the existence of improper
machine settings but instead claimed only that he "did nbt see"
the improper settings.

In addition, the Trust contended that

Ms. Marler misinterpreted Dr. Kisslo's illustration of available
Nyquist levels as acceptable levels.

Finally, the Trust

5.
See Settlement Agreement § IV.A.1.a. (Screening
established under the Settlement Agreement) .
-7-

i

Prog~am
'

contended that neither claimant nor her experts refuted
Dr. Kisslo's findings with respect to the pattern of manipulation
found in studies performed by the company that performed
Ms. Marler's echocardiogram.
Claimant disputed the Trust's final determination and
requested that her claim proceed through the show cause process
established in the Settlement Agreement.

See Settlement

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

The Trust

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

On September 26, 2007, we

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

See PTO No. 7439

(Sept. 26, 2007).
Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
documentation.

Claimant then served a response upon the Special

Master, relying upon the arguments made in contest.

On

April 14, 2008, the Trust informed the Special Master that it
intended to reply upon the documents previously submitted and the
arguments that it already raised.

Under the Audit Rules, it is

within the Special Master's discretion to appoint a Technical
Advisor 6 to review claims after the Trust and claimant have had

6. 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 this, where
(continued ... )
-8-

the opportunity to develop the Show Cause Record.
30.

See Audit Rule

The Special Master assigned Technical Advisor, Gary J.

Vigilante, M.D., F.A.C.C., to review the documents submitted by
the Trust and claimant and 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 her claim. 7

Where the Trust's

post-audit determination finds intentional material
misrepresentations of fact,

the claimant has the burden of

proving that all representations of material fact in connection
with her claim are true.

See id. Rule 24.

Ultimately, if we

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

See id. Rule 38(a).

If, on

the other hand, we determine that there is a reasonable medical
basis for the answers with no intentional material

6.
( ... continued)
conflicting expert opinions exist, it is within the discretion of
the court to appoint a Technical Advisor to aid it in re,solving
technical issues.
Id.
7. Given our disposition with respect to claimant's level of
mitral regurgitation, we need not determine whether there is a
reasonable medical basis for finding that claimant suffered from
one of the necessary complicating factors.
-9-

misrepresentations of fact made in connection with the claim, we
must enter an Order directing the Trust to pay the claim in
accordance with the Settlement Agreement.

See id. Rule 38{b).

The Technical Advisor, Dr. Vigilante, reviewed
claimant's echocardiogram and concluded that it was not conducted
in a manner consistent with medical standards.

Specifically,

Dr. Vigilante observed:
There was increased echo gain noted in all
views with significantly increased sparkling
of myocardial tissue.
In addition, there was
obvious excessive color gain causing color
artifact within the myocardial tissue and
outside of the heart.
There was persistence
with "stuttering" of cardiac images noted
with systolic color images seen during
diastolic echo images. An inappropriately
low Nyquist limit of 51 cm per second was
noted at a depth of 13.5 cm in the
parasternal long axis and apical views.
In
addition, low velocity and non-mitral
regurgitant flow was measured as part of the
supposed RJA by the sonographer in this
study. An off-axis view of the left atrium
was used to inappropriately measure the LAA.
Despite these deficiencies, Dr. Vigilante noted that he
was able to evaluate claimant's echocardiogram and determined
that there was no reasonable medical basis for the attesting
physician's finding that claimant had moderate mitral
regurgitation.

Dr. Vigilante explained, in pertinent part, that:

A thin and short jet of mitral regurgitation
was noted in the parasternal long-axis view.
Visually, mild mitral regurgitation was noted
in the apical four chamber and two chamber
views.
I digitized the cardiac cycles in the
apical four and two chambers views.
In spite
of excessive echo and color gain as well as
persistence and a low Nyquist limit, I was
able to accurately planimeter the RJA in the
-10-

mid portion of systole. The largest RJA in
the apical four chamber view was 1.0 cm2.
The largest RJA in the apical two chamber
view was 1.3 cm2.
I was able to accurately
determine the LAA in this study. The LAA was
11.4 cm2. Therefore, the largest RJA/LAA
ratio was less than 12%. Most of the RJA/LAA
ratios were less than 7%. The RJA/LAA ratio
never came close to approaching 20%. There
was one supposed regurgitant jet area
measured by the sonographer. This
measurement was 2.47 cm2 taken in the apical
four chamber view. This measurement was not
representative of mitral regurgitation and
included low velocity and non-mitral
regurgitant flow at the beginning of systole
and immediately after the QRS complex. This
jet was a reflection of backflow and not
mitral regurgitation. The sonographer
measured the LAA to be 8.71 cm2 in the apical
four chamber view. This measurement was
inaccurate and taken in an off-axis view.
The correct LAA was 11.4 cm2. The
sonographer's inaccurate RJA and LAA
determinations provide an RJA/LAA ratio of
28% which is the same ratio documented by
Dr. Brazil in his formal echocardiogram
report.
In response to the Technical Advisor Report, claimant
argues that there is no intentional material misrepresentation of
fact because each cardiologist was able to evaluate the
echocardiogram and that the differences among the readings "was
simply the extent of the mitral valve regurgitation."
After reviewing the entire show cause record, we find
claimant has not established a reasonable medical basis for the
attesting physician's finding that Ms. Marler had moderate mitral
regurgitation.

In reaching this determination, we are required

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

In this context, we previously have explained that

-11-

conduct "beyond the bounds of medical reason" can include:
failing to review multiple loops and still frames;

(1)

(2) failing to

have a Board Certified Cardiologist properly supervise and
interpret the echocardiogram;

(3) failing to examine the

regurgitant jet throughout a portion of systole;
manipulating echocardiogram settings;
limit;

(4) over-

(5) setting a low Nyquist

( 6) characterizing "artifacts," "phantom jets," "backflow"

and other low velocity flow as mitral regurgitation;

(7) failing

to take a claimant's medical history; and (8) overtracing the
amount of a claimant's regurgitation.

See Mem. in Supp. of PTO

No. 2640, at 9-13, 15, 21-22, 26 (Nov. 14, 2002).
Here, Dr. Kisslo and Dr. Vigilante each found that
claimant's sonographer improperly selected, traced and measured a
supposed regurgitant "jet."

According to Dr. Vigilante, the

sonographer's measurements of claimant's RJA "was not
representative of mitral regurgitation and included low velocity
and non-mitral regurgitant flow."

In addition, Dr. Kisslo and

Dr. Vigilante found that the echocardiogram of attestation was
not conducted in a manner consistent with medical standards
because, among other things, the echocardiogram settings included
high color gain and an inappropriately low Nyquist.
Notwithstanding these deficiencies, Dr. Kisslo and
Dr. Vigilante determined that Ms. Marler's echocardiogram
demonstrated only mild mitral regurgitation.

In addition,

Dr. Vigilante concluded, after a thorough review, that there was
no reasonable medical basis for the attesting physician's opinion
-12-

that Ms. Marler had moderate mitral regurgitation.

Specifically,

he explained that "the largest RJA/LAA ratio was 12% 11 and that
"[m]ost of the RJA/LAA ratios were less than 7%."
Claimant does not substantively challenge the specific
findings with respect to the manner in which her level of mitral
regurgitation was evaluated.

Dr. Brazil disputes that the

inappropriate measurements of the sonographer influenced his
determination of claimant's level of mitral regurgitation or that
any inappropriate settings were used in performing Ms. Marler's
echocardiogram, but he does not identify any particular error in
the determinations of Dr. Kisslo or Dr. Vigilante that claimant's
echocardiogram does not demonstrate moderate mitral
regurgitation. 8

A claimant cannot carry her burden when, like

here, her expert merely states in conclusory fashion that the
echocardiogram at issue does, in fact, demonstrate the requisite
level of mitral regurgitation. 9
We conclude, based on our review of the entire record,
that there is no reasonable medical basis for Dr. Brazil's
representation that claimant had moderate mitral regurgitation.
Thus, we need not determine whether there was, in fact, any

8.
In addition, Dr. Vigilante noted that the sonographer's
measurements on the echocardiogram tape resulted in the exact
percentage Dr. Brazil noted in his report of claimant's
echocardiogram.
9. Thus, we reject claimant's argument that there is a
reasonable medical basis for her claim simply because he+
attesting physician, Dr. Brazil, participated in the Trust's
Screening Program.
-13-

intentional material misrepresentation of fact in connection with
Ms. Marler' s claim . 10
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. Marler's claim for Matrix Benefits.

10. As we previously have stated, 11 [s]imply because an
undeserving claim has slipped through the cracks so far is no
reason for this court to put its imprimatur on a procedure which
may allow it to be paid. 11 Mem. in Supp. of PTO No. 5625!, at 6-7
(Aug. 24, 2005) . In this same vein, we will not ignore ;the
findings of other cardiologists simply because a claim bias
previously passed audit.
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