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

Filing 4982

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9192 RE: CLAIMANT VIVIAN A. LAMBERT. SIGNED BY HONORABLE HARVEY BARTLE, III ON 1/9/2014; 1/9/2014 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110197 IN 11-MD-1203). (tjd)

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.

qil CJ L

January Cf , 2014

Bartle, J.

Vivian A. Lambert ("Ms. Lambert" or "claimant"), a
class member under the Diet Drug Nationwide Class Action
Settlement Agreement ("Settlement Agreement") with Wyeth,
benefits from the AHP Settlement Trust ("Trust").

1

seeks

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 misrepresentations of fact.

2

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

1.

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 firsd 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 August, 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 27, 2002, Dr. Brazil attested in Part II of claimant's Green
Form that Ms. Lambert suffered from moderate mitral
regurgitation, an abnormal left atrial dimension, and a reduced

2.
( ... continued)
for compensation purposes based upon the severity of the.ir
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 seribus 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-

ejection fraction in the range of 50% to 60%. 3

Based on such

findings, claimant would be entitled to Matrix A-1, Level II
benefits in the amount of $496,153. 4
In the report of claimant's echocardiogram, Dr. Brazil
observed that Ms. Lambert had "moderate mitral regurgitation with
a regurgitant jet area to left atrial area ratio of 20%.

11

Under

the definition set forth in the Settlement Agreement, moderate or
greater mitral regurgitation is present where the Regurgitant Jet
Area ( 11 RJA 11 )

in any apical view is equal to or greater than 20%

of the Left Atrial Area ( 11 LAA 11 ) .
§

I.22.

See Settlement Agreement

Dr. Brazil also measured Ms. Lambert's left atrial

antero-posterior dimension as 4.7 cm and her left atrial
supero-inferior dimension as 5.8 cm.

The Settlement Agreement

defines an abnormal left atrial dimension as a left atrial
antero-posterior systolic dimension greater than 4.0 cm in the
parasternal long-axis view or a left atrial

supero-infer~or

systolic dimension greater than 5.3 cm in the apical four chamber
view.

See id.

§

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

In addition, Dr. Brazil

determined that Ms. Lambert had an ejection fraction of 60%.

An

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

ejection fraction is considered reduced for purposes of

a

mitral

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

§

See

IV . B . 2 . c . ( 2 ) ( b) iv) .
In January, 2004, the Trust forwarded the

clai~

for

review by Zuyue Wang, M.D., F.A.C.C., one of its auditing
cardiologists.

In audit, Dr. Wang determined that there was a

reasonable medical basis for Dr. Brazil's findings that
Ms. Lambert had moderate mitral regurgitation and an abnormal
left atrial dimension.
Based on Dr. Wang's findings, the Trust issued a
post-audit determination letter awarding Ms. Lambert Matrix
Benefits.

Before the Trust paid Ms. Lambert's claim, we imposed

a stay on the processing of claims pending implementation of the
Seventh Amendment to the Settlement agreement.
Order ("PTO") No. 3511 (May 10, 2004).

See Pretrial

Prior to the entry of the

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

Pursuant to

Paragraph 5 of PTO No. 3883, the Trust was ordered to separate
the Pre-Stay PADL Claims into three categories.

Of the 968

Pre-Stay Payable PADL Claims, the Trust alleged that 580 claims,
including Ms. Lambert's, contained intentional material
misrepresentations of fact.
referred to as "5(a) claims."

These 580 claims are commonly
See PTO No. 3883,

(Aug. 26, 2004).

-4-

at~

5

Following the end of the stay, we ordered the Trust to
review the 580 claims designated as 5(a) claims and issue new
post-audit determinations, which claimants could contest.
PTO No. 5625 (Aug. 24, 2005).

See

On November 22, 2006, prior to the

Trust's review of Ms. Lambert's claim, this court approved Court
Approved Procedure ("CAP") No. 13, which provided 5 (a) c.laimants
with the option either to submit their claims to a binding
medical review by a participating physician or to opt-out of CAP
No. 13.

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

Ms. Lambert elected

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

As part of this

review, the Trust engaged Joseph Kisslo, M.D., to review the
integrity of the echocardiogram system used during the
performance of echocardiographic studies and the resulting
interpretations submitted in support of Ms. Lambert's claim. 5

As

5.
In November, 2004, the Trust had provided Ms. Lambert with an
"Expert Report" signed by Dr. Kisslo pursuant to Paragraph 11 of
PTO No. 3883.
In that report, Dr. Kisslo opined that claimant's
echocardiogram "evidences a misrepresentation of the severity of
mitral regurgitation" because:
(1) "[e] xcessive and clinically
unacceptable color gain was utilized in acquiring Ms. Lambert's
echocardiogram"; (2) "[c]olor persistence by interpolation on the
Acuson Cypress [echocardiogram] machine blended one frame of
color data on top of another in the study, distorting the
temporal timing information and duration of the regurgitant jet";
(3) "the [echocardiogram] examiner inappropriately used a low
Nyquist setting, causing the velocity scale of all flow,
including the alleged jet, to be remapped and amplified in
brightness and size"; and (4) "[t]he two-dimensional
( cont;i.nued ... )
-5-

stated in his March 1, 2007 declaration, Dr. Kisslo determined,
in pertinent part, that:
In Ms. Lambert's study, the use of high color
gain, excessive depth, a decreased Nyquist
setting, high image gain and color pixels
dominant over anatomy and the overmeasurement
of the mitral 11 jet, 11 as well as the
undermeasurement of the left atrial area and
the overmeasurement of the left atrial
dimension are the result of deliberate
choices and conduct engaged in by the
sonographer performing this study and at a
minimum, acquiesced in by the Attesting
Physician.
Each of these manipulations
exaggerated or created the appearance of
regurgitation, jet duration or a complicating
factor.
There is no responsible physiologic
or hemodynamic construct under which this
echocardiogram can be assessed as
demonstrating moderate mitral and aortic
regurgitation. Ms. Lambert has only trivial
mitral and aortic regurgitation-not moderate
mitral and aortic regurgitation as claimed by
the Attesting Physician. 6
Thus, notwithstanding Dr. Wang's findings at

a~dit,

the

Trust rescinded its prior post-audit determination letter and
issued a new post-audit determination denying Ms. Lambert's claim
based on its conclusion that there was substantial evidence of
intentional material misrepresentations of fact in connection
with the claim.

Pursuant to the Rules for the Audit of Matrix

Compensation Claims ("Audit Rules"), Ms. Lambert contested this

5.
( ... continued)
echocardiogram demonstrated excessive gain.

11

6.
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
-6-

adverse determination. 7

In contest, Ms. Lambert argued that her

echocardiogram was performed in a manner consistent with the
standards set forth in the Settlement Agreement.
claimant submitted affidavits from:

In support,

Dr. Brazil; Lynda F.

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

In his affidavit, Dr. Brazil stated, in

pertinent part, that:
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

7.
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. Lambert's claim.
-7-

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

Finally,

Ms. Lollar-Goldstein observed 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 maintained that her echocardiogram
demonstrated moderate mitral regurgitation.

In his declaration,

Dr. Brazil stated that he had reviewed Ms. Lambert's
echocardiogram and concluded that it "demonstrates that there was
-8-

moderate mitral regurgitation with a regurgitant jet area to left
atrial area ratio of 20%."

In addition, Ms. Lambert noted that

Dr. Brazil participated in the Trust's Screening Program. 8
The Trust then issued a final post-audit determination,
again denying Ms. Lambert's claim.

The Trust asserted that

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

The Trust also contended 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 submitted that

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

Finally, the Trust. argued

that neither claimant nor her experts refuted Dr. Kisslo.' s
findings with respect to the pattern of manipulation fouhd in
studies performed by the company that performed Ms. Lambert'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. Lambert's claim should be paid.

On September 26, 2007,

we issued an Order to show cause and ref erred the matter to the

8.
See Settlement Agreement § IV.A.l.a. (Screening Program
established under the Settlement Agreement) .
-9-

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 it intended
to reply upon the documents previously submitted and the
arguments that it had already raised.

Under the Audit Rules, it

is within the Special Master's discretion to appoint a Technical
Advisor 9 to review claims after the Trust and claimant have had
the opportunity to develop the Show Cause Record.
Rule 30.

See Audit

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

9. A 11 [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 Stat~s, 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-

reasonable medical basis for her claim. 10

Where the Truse•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
must affirm the Trust's final determination and may
other relief as deemed appropriate.

r~ason,

gran~

See id. Rule 38(a).

the other hand, we determine that there is a reasonable

we

such
If, on

~edical

basis for the answers with no intentional material
misrepresentations of fact made in connection with the claim, we
must enter an Order directing the Trust to pay the claim in
accordance with the Settlement Agreement.

See id. Rule 38(b).

The Technical Advisor, Dr. Vigilante, reviewed
Ms. Lambert's echocardiogram and concluded that it was not
conducted in a manner consistent with medical standards.
Specifically, Dr. Vigilante observed:
The usual echocardiographic views were
obtained. However, the study was not
conducted in a manner consistent with medical
standards.
There was significantly increased
echo gain noted in both the parasternal and
apical views. There was obvious excessive
color gain causing color artifact within the

10. 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.
-11-

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
particularly in the apical views. An
inappropriately low Nyquist limit of 41 cm
per second was noted at a depth of 19.0 cm in
both the parasternal and apical views.
Color
pixels dominant over anatomy was [sic] noted
in the apical views. Low velocity and nonmitral regurgitant flow was measured as part
of the supposed RJA by the sonographer on the
study. An off-axis view of the left atrium
was used to inappropriately measure the LAA.
The left atrial dimension was also
inaccurately measured.
Despite these deficiencies, Dr. Vigilante notea that he
was able to evaluate claimant's echocardiogram and deterruined
that there was no reasonable medical basis for the attesting
physician's finding that Ms. Lambert had moderate mitral
regurgitation.

Dr. Vigilante explained, in pertinent part:

A thin and short jet of mitral regurgitation
was noted in the apical four chamber view.
Visually, only trace mitral regurgitation was
noted in the apical views.
I digitized the
cardiac cycles in the apical four and two
chamber 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 mid portion of
systole. The largest RJA in the apical four
chamber view was 1.4 cm2.
The largest RJA in
the apical two chamber view was 1.3 cm2.
I
was able to accurately determine the LAA in
the study. The LAA was 23.3 cm2. Therefore,
the largest RJA/LAA ratio was 6%. Most of
the RJA/LAA ratios were less than 4%.
The
RJA/LAA ratio never came close to approaching
20%.
There were two supposed RJA's and LAA's
measured by the sonographer. The sonographer
measured an RJA of 2.95 cm2 and a LAA of
21.88 cm2 in the apical four chamber view.
The sonographer measured an RJA of 2.83 cm2
and a LAA of 14.47 cm2 in the apical two
chamber view. These RJA measurements were
-12-

not representative of mitral regurgitation
and included low velocity and non-mitral
regurgitant flow at the beginning of systole
and immediately at the QRS complex.
These
jets were reflections of backflow and not
mitral regurgitation.
The sonographer's LAA
measurement of 14.47 cm2 in the apical two
chamber view is significantly off-axis and
not even close to the accurate LAA
measurement of 23.3 cm2. The sonographer•s
inaccurate RJA and LAA determinations in the
apical two chamber view provide an RJA/LAA
ratio of 20% 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. Lambert had moderate
mitral regurgitation.

In reaching this determination, we are

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

In the context of those two

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

(1) failing to review

(2) failing to have a Bbard

Certified Cardiologist properly supervise and interpret the
echocardiogram;

(3) failing to examine the regurgitant jet

throughout a portion of systole;
echocardiogram settings;

(4) over-manipulating

(5) setting a low Nyquist limit;
-13-

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

11

other low velocity flow as mitral regurgitation;

backflow 11 and
(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

11

jet.

11

According to Dr. Vigilante,

11

[l]ow

velocity and non-mitral regurgitant flow was measured as: part of
the supposed RJA by the sonographer on the study."

In aO.dition,

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 excessive color gain, color persistence, an
inappropriately low Nyquist, excessive image gain, and color
pixels dominant over anatomy in order to exaggerate the
appearance of mitral regurgitation.
Notwithstanding these deficiencies, Dr. Kisslo and
Dr. Vigilante determined that Ms. Lambert's echocardiogram
demonstrated, at most, only very 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 that Ms. Lambert had moderate mitral
regurgitation.

Specifically, he explained that "the largest

RJA/LAA ratio was 6% 11 and that "[m]ost of the RJA/LAA ra:tios were
less than 4%."
-14-

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 mi tral regurgi tatio;n or that
any inappropriate settings were used in performing Ms. Lambert'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.

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. 11
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
intentional material misrepresentation of fact in connection with
Ms. Lambert's claim. 12
11. Thus, we reject claimant's argument that there is a
reasonable medical basis for her claim simply because her
attesting physician, Dr. Brazil, participated in the Trust's
Screening Program.
12. As we previously have stated, "[s]imply because an
undeserving claim has slipped through the cracks so far ~s no
reason for this court to put its imprimatur on a procedure which
may allow it to be paid." Mem. in Supp. of PTO No. 5625, at 6-7
(Aug. 24, 2005).
In this same vein, we will not ignore ~he
findings of other cardiologists simply because a claim has
(continued ... )
-15-

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.

Therefore, we will affirm the

Trust's denial of Ms. Lambert's claim for Matrix Benefits.

12.
( ... continued)
previously passed audit.
-16-