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

Filing 4216

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.8631 RE: CLAIMANT REBECCA THOMPSON. SIGNED BY HONORABLE HARVEY BARTLE, III ON 4/1/2011; 4/4/2011 ENTERED AND COPIES MAILED AND DISTRIBUTED TO LIAISON COUNSEL. (SEE 11-MD-1203 PAPER NO.109414). (kk, )

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, C.J.

'i(P;S (

April

, , 2011

Rebecca Thompson ("Ms. Thompson" 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")

.2

1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
2. Matrix Benefits are paid according to two benefit matrices
(Matrix "N' 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 (IIVHD").
See
(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 August, 2002, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Azam Ansari,
M.D., F.A.C.C.

Dr. Ansari is no stranger to this litigation.

According to the Trust, he has signed in excess of 163 Green
Forms on behalf of claimants seeking Matrix Benefits.

Based on

an echocardiogram dated March 13, 2002, Dr. Ansari attested in
Part II of Ms. Thompson's Green Form that she suffered from
moderate mitral regurgitation and a reduced ejection fraction in

2.
( ... continued)
Settlement Agreement §§ IV.B.2.b. & IV.B.2.d. (1)-(2). Matrix A-I
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 drug.
-2­

the range of 50% to 60%.3

Based on such findings,

claimant would

be entitled to Matrix A-I, Level II benefits in the amount of
$545,310. 4
In the report of claimant's echocardiogram, Dr. Ansari
stated that claimant had llmoderate mitral regurgitation, which
occupied 20% of the left atrial volume.

ll

Under the definition

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

See Settlement Agreement

§

1.22.

Dr. Ansari also measured claimant's left atrial dimension as
3.6 cm in the parasternal long-axis view and stated that
is biatrial enlargement ll in the apical four chamber view.

II

[t]here
The

Settlement Agreement defines an abnormal left atrial dimension as
a left atrial supero-inferior systolic dimension greater than

3. Dr. Ansari also attested that claimant suffered from moderate
aortic regurgitation. As Ms. Thompson's claim does not present
any of the complicating factors necessary to receive Matrix
Benefits for damage to her aortic valve, her level of aortic
regurgitation is not relevant to this claim.
See Settlement
Agreement § IV.B.2.c. (2) (a).
4.
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).
Claimant has
conceded that she does not have a reduced ejection fraction,
which is one of the complicating factors needed to qualify for a
Level II claim.
Claimant, however, contends that Dr. Ansari
inadvertently checked "No" in responding to the Green Form
question regarding whether she had an enlarged left atrial
dimension, which is one of the other complicating factors needed
to qualify for a Level II claim.
-3­

5.3 cm in the apical four chamber view or a left atrial
antero-posterior systolic dimension greater than 4.0 cm in the
parasternal long-axis view.

See id.

In October, 2003, the Trust forwarded the claim for
review by Alan J. Bier, M.D., one of its auditing cardiologists.
In audit, Dr. Bier concluded that there was no reasonable medical
basis for Dr. Ansari's finding that claimant had moderate mitral
regurgitation because her echocardiogram demonstrated only mild
mitral regurgitation.

In support of this conclusion, Dr. Bier

explained that:
Only slight (mitral regurgitation] was seen
in all projections. Traced jet area includes
both low velocities of normal flow and sub­
threshold velocities.
Despite that, the area
they report is only 20%, borderline even with
this major overestimate of jet size.
Dr. Bier also measured claimant's left atrial dimension as 4.0 cm
in the parasternal long-axis view and 4.9 cm in the apical four
chamber view.

Both measurements are within the range of normal

under the Settlement Agreement.
Based on the auditing cardiologist's findings,

the

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

Pursuant to the Rules for the Audit of Matrix

Compensation Claims ("Audit Rules"), claimant contested this
adverse determination. 5

In contest, claimant submitted a

5.
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 (npTon) No. 2457 (May 31, 2002).
Claims placed into audit
(continued ... )
-4­

supplemental opinion from Dr. Ansari, who confirmed his findings
of moderate mitral regurgitation and left atrial enlargement and
attached still frames from claimant's echocardiogram, which
purportedly demonstrated these conditions.
asserted that:

Claimant also

(1) the auditing cardiologist only visually

assessed her level of mitral regurgitation as opposed to taking
actual measurements;

(2) the Green Form does not have the same

answer choices as the Auditor's Report; and (3) the Trust failed
to specify the auditing cardiologist's credentials in connection
with its denial. 6
The Trust then issued a final post-audit determination,
again denying Ms. Thompson's claim.

Claimant disputed this final

determination and requested that the claim proceed to the show
cause process established in the Settlement Agreement.
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. Thompson's claim should be paid.

On

November 10, 2004, we issued an Order to show cause and referred
5.
( ... continued)
after December I, 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. Thompson's claims.
6. The Trust provided claimant with Dr. Bier's credentials with
its final post-audit determination.
In contest, claimant also
had argued that the auditing cardiologist failed to declare under
penalty of perjury that the information contained in the Report
of the Auditing Cardiologist was correct to the best of his
knowledge. Dr. Bier signed an Attestation Form dated
November 2, 2003 and a Certification dated October 26, 2004
averring that his findings were true and correct.
-5­

the matter to the Special Master for further proceedings.

See

PTO No. 4135 (Nov. 10, 2004).
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 June 8, 2005, and

claimant submitted a sur-reply on June 30, 2005.

Under the Audit

Rules, it is within the Special Master's discretion to appoint a
Technical Advisor7 to review claims after the Trust and claimant
have had the opportunity to develop the Show Cause Record.
Audit Rule 30.

See

The Special Master assigned a Technical Advisor,

Sandra V. Abramson, 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 in proving that there is a
reasonable medical bas

for finding that she had moderate mitral

regurgitation and an abnormal left atrial dimension.

See

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, such as this, where there
are conflicting expert opinions, a court may seek the assistance
of the Technical Advisor to reconcile such opinions. The use of
a Technical Advisor to "reconcil[e] the testimony of at least two
outstanding experts who take opposite positions" is proper.
Id.
-6­

Rule 24.

ultimately, if we determine that there is no reasonable

medical basis for the answers in claimant's Green Form that are
at issue, we must affirm the Trust's final determination and may
grant such other relief as deemed appropriate.
Rule 38(a).

See id.

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

reasonable medical basis for the answers, we must enter an Order
directing the Trust to pay the claim in accordance with the
Settlement Agreement.

See id. Rule 38(b).

In support of her claim, Ms. Thompson reasserts the
arguments she made in contest.

Claimant also argues that:

(1) the auditing cardiologist "selectively downgraded" her level
of mitral regurgitation from moderate to mild;

(2) the Trust

cannot modify the definition of mitral regurgitation by
referencing "low velocity" flow or "sub-threshold velocities";
and (3) the auditing cardiologist's findings are unverifiable.
Claimant further criticizes the Trust's administration of claims
and argues that the audit process is unfair to claimants.
In response, the Trust disputes that the auditing
cardiologist selectively downgraded claimant's level of mitral
regurgitation.

Instead, the Trust explains that the auditing

cardiologist concluded that there was no reasonable medical basis
to find moderate mitral regurgitation because the attesting
physician relied on "planimetry that was significantly
overtraced."

The Trust also asserts that claimant cannot

establish a claim for Matrix Benefits because she failed to
demonstrate the existence of a complicating factor.
7

The Trust

further contends that the auditing cardiologist complied with the
Settlement Agreement in assessing claimant's level of mitral
regurgitation.

Finally, the Trust argues that the additional

possible responses regarding the level of a claimant's mitral
regurgitation included in the Report of the Auditing Cardiologist
have no effect on the outcome of claims and that claimant's
criticisms of the Trust's administration of claims are beyond the
scope of the show cause proceedings.
In her sur reply, claimant argues that while the
auditing cardiologist's findings are not substantiated by any
independent evidence, the attesting physician's findings are
based on computerized assessments and still frames, which,
according to claimant, provide a reasonable medical basis for her
claim.

Claimant again contends that the Trust is attempting to

modify the definition of mitral regurgitation.
The Technical Advisor, Dr. Abramson, reviewed
claimant's echocardiogram and concluded that there was no
reasonable medical basis for the attesting physician's findings
that claimant had moderate mitral regurgitation and an abnormal
left atrial dimension.

Dr. Abramson measured claimant's mitral

regurgitant jet in four representative cardiac cycles and
obtained ratios of "13%, 14%, 14%, and 14%, all of which are
considerably less than 20%, which is consistent with mild mitral
regurgitation.

II

Dr. Abramson also determined that the tracings

made by the sonographer and the tracings submitted by Dr. Ansari

8­

do not depict mitral regurgitation.

Specifically, Dr. Abramson

found that:
The one tracing performed by the sonographer
includes color flow areas unrelated to the
mitral regurgitation. At meter number
41:09:16 the RJA traced by the sonographer
was measured at 4.48cm 2 •
I remeasured the
same jet at 2.S6cm2. The tracings that were
submitted in Exhibit II (Dr. Ansari) do not
show the regurgitant jet area and left atrial
area tracings in the same cardiac cycle.
Also, low velocity flow is included in his
tracing of the mitral regurgitant jet.
Dr. Abramson also concluded that claimant's left atrial dimension
was "within normal limits and could not reasonably be read as
abnormal."

In addition, she found that" [t]he measurements in

the apical view on the tape include pulmonary veins.

If

In response to the Technical Advisor Report, claimant
argues that Dr. Abramson's conclusions are unsubstantiated.
Claimant also contends that, by referencing low velocity flow,
Dr. Bier and Dr. Abramson have attempted to rewrite the
Settlement Agreement definition of mitral regurgitation.
Additionally, claimant dismisses Dr. Abramson's finding that she
had a normal left atrial dimension as a "non-verifiable assertion
without an exhibit."

Finally, claimant argues that there is a

reasonable medical basis for her claim based on the verifiable
documentation that was provided by Dr. Ansari.8

8. Claimant additionally contends that Dr. Abramson lacks the
necessary credentials to be a Technical Advisor as set forth in
Audit Rule 32. We disagree. We appointed Dr. Abramson to assist
the court in reviewing certain claims in the show cause process
after finding that she possessed the requisite skills and
(continued ... )
9­

After reviewing the entire Show Cause Record, we find
claimant's arguments are without merit.

First, we disagree with

claimant that the auditing cardiologist's findings lack
verifiable evidence and that Dr. Abramson did not substantiate
her findings.

To the contrary, the auditing cardiologist

identified specific deficiencies with Dr. Ansari's measurements;
namely, that he traced jet areas that included "both low
velocities of normal flow and sub-threshold velocities."l)
Similarly, Dr. Abramson concluded that Dr. Ansari relied upon
non-representative regurgitant jets, improperly considered low
velocity flow in his measurements, and included claimant's
pulmonary vein in measuring claimant's left atrium.

On these

bases alone, claimant has failed to meet her burden of
demonstrating that there is a reasonable medical basis for her
claim.lo
We also disagree with claimant that low velocity flow
is considered mitral regurgitation.

As we previously explained

in PTa No. 2640, conduct "beyond the bounds of medical reason"
can include:
frames;

(1) failing to review multiple loops and still

(2) failing to have a Board Certified Cardiologist

8.
( ... continued)

expertise. See PTa No. 3212 (Jan. 14, 2002).

9.
The auditing cardiologist, therefore, did not selectively

downgrade claimant's level of mitral regurgitation from moderate

to mild.

10. For these reasons as well, the still frames submitted by

claimant are insufficient to establish a reasonable medical basis

for her claim.

-10­

properly supervise and interpret the echocardiogram;

(3) failing

to examine the regurgitant jet throughout a portion of systole;
(4) over-manipulating echocardiogram settings;
Nyquist limit;

(5) setting a low

(6) characterizing "artifacts," I1phantom 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,
PTO No, 2640 at 9-13, 15, 21-22, 26 (Nov. 14, 2002).

See

Here, both

Dr. Bier and Dr, Abramson concluded that Dr, Ansari improperly
included low velocity flow in his measurements of claimant's
mitral regurgitation,

Dr. Abramson also found that Dr. Ansari

inflated claimantls left atrial dimension by improperly including
pulmonary veins in his measurements.

Such unacceptable practices

cannot provide a reasonable medical basis for the resulting
diagnoses and Green Form answers.
Moreover, we disagree with claimant's arguments
concerning the required method for evaluating a claimant's level
of valvular regurgitation.

Although the Settlement Agreement

specifies the percentage of regurgitation needed to qualify as
having moderate mitral regurgitation, it does not specify that
actual measurements must be made on an echocardiogram.
explained in PTO No, 2640,

III

As we

[e]yeballing' the regurgitant jet to

assess severity is well accepted in the world of cardiology."
See

at 15,

Claimant essentially requests that we write into

the Settlement Agreement a requirement that actual measurements
of mitral regurgitation be made to determine if a claimant
-11

qualif

for Matrix Benefits.

There is no basis for such a

revision and claimant's argument is contrary to the "eyeballing"
standards we previously have evaluated and accepted in
PTO No. 2640. 11

Finally, we disagree with claimant's assertion that the
Trust's audit system is unfair to claimants.

It is claimant's

burden in the show cause process to show why she is entitled to
Matrix Benefits.

process

See Audit Rule 24.

The audit and show cause

as approved by this court, provide claimant with notice

l

and an opportunity to present her evidence in support of her
claim.12

Claimant has not provided any evidence that the audit

of her claim was not done in an objective manner.

Wei therefore

I

reject claimant's challenge to the audit process.
For the foregoing reasons

I

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 and an abnormal left atrial dimension.

Therefore

I

we will affirm the Trust's denial of Ms. Thompson's claim for
Matrix Benefits.

11.
Claimant's argument also fails because the Technical
Advisor although not required to, measured her level of mitral
regurgitation which further establishes that claimant is not
entitled to Matrix Benefits.
l

l

12.
We reject claimant's argument that there are inconsistencies
between the possible answers on the Green Form and the Auditor's
Report. Although the Auditor's Report includes additional
selections for the level of mitral regurgitation and ejection
fraction these choices have no bearing on whether a claimant is
eligible for Matrix Benefits.
l

12