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

Filing 4250

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 8656 RE: CHRISTINE A. ZAFFRAN. SIGNED BY HONORABLE HARVEY BARTLE, III ON 7/20/2011; 7/21/2011 ENTERED AND COPIES MAILED AND E-MAILED. (SEE PAPER # 109447 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
)
___________________________________)
)
THIS DOCUMENT RELATES TO:
)
)
SHEILA BROWN, et al.
)
)
v.
)
)
AMERICAN HOME PRODUCTS
)
CORPORATION
)

MDL NO. 1203

CIVIL ACTION NO. 99-20593
2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.
Bartle, J.

July 20, 2011
Christine A. Zaffran ("Ms. Zaffran" or "claimant"), a

class member under the Diet Drug Nationwide Class Action
Settlement Agreement ("Settlement Agreement") with Wyeth,1 seeks
benefits from the AHP Settlement Trust ("Trust").2

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").3

1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
2. Kenneth B. Zaffran, Ms. Zaffran's spouse, also has submitted
a derivative claim for benefits.
3.

Matrix Benefits are paid according to two benefit matrices
(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 March, 2003, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Azam Ansari,
M.D., F.A.C.C.

Based on an echocardiogram dated

September 25, 2002, Dr. Ansari attested in Part II of
Ms. Zaffran's Green Form that she suffered from moderate mitral

3. (...continued)
(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
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.
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regurgitation,4 pulmonary hypertension second to moderate or
greater mitral regurgitation, an abnormal left atrial dimension,
and a reduced ejection fraction in the range of 50% to 60%.5
Based on such findings, claimant would be entitled to Matrix A-1,
Level II benefits in the amount of $512,025.6
In the report of claimant's echocardiogram, Dr. Ansari
stated that claimant had "moderate mitral regurgitation, which
occupied 39% of the left atrial surface."

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").

See Settlement Agreement § I.22.

4. Dr. Ansari also attested that claimant suffered from moderate
aortic regurgitation. As Ms. Zaffran'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 case. See Settlement
Agreement § IV.B.2.c.(2)(a).
5. Dr. Ansari also attested that claimant suffered from New York
Heart Association Functional Class I symptoms. This condition,
however, is not at issue in this claim.
6. 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). Pulmonary
hypertension secondary to moderate or greater mitral
regurgitation, an abnormal left atrial dimension, and a reduced
ejection fraction are each one of the complicating factors needed
to qualify for a Level II claim. As the Trust concedes that
Ms. Zaffran suffers from pulmonary hypertension, the only issue
is claimant's level of mitral regurgitation.
-3-

In October, 2005, the Trust forwarded the claim for
review by David I. Silverman, M.D., one of its auditing
cardiologists.

In audit, Dr. Silverman concluded that there was

no reasonable medical basis for the attesting physician's finding
that claimant had moderate mitral regurgitation because her
echocardiogram demonstrated only mild regurgitation.

In support

of this conclusion, Dr. Silverman explained that claimant had a
"[m]aximum RJA/LAA ratio [of] 4/21=19%, below [the] threshold for
moderate [mitral regurgitation]."
Based on the auditing cardiologist's finding that
claimant had mild mitral regurgitation, the Trust issued a postaudit determination denying Ms. Zaffran's claim.

Pursuant to the

Rules for the Audit of Matrix Compensation Claims ("Audit
Rules"), claimant contested this adverse determination.7

In

contest, claimant argued that there was a reasonable medical
basis for Dr. Ansari's Green Form representation that Ms. Zaffran
suffered from moderate mitral regurgitation.

Claimant submitted

a letter from Dr. Ansari wherein he stated that he again reviewed
Ms. Zaffran's echocardiogram and confirmed that her level of

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 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. Zaffran's claim.
-4-

mitral regurgitation was moderate at 30% to 33%, and not mild.
In support, Dr. Ansari attached several still-frame images, which
purportedly demonstrated moderate mitral regurgitation, and
explained, "Computer-assisted visual assessment indicates [19%
regurgitation] is impossible....

Only three index jets (33%) can

fit in two different LAAs...."
The Trust issued a final post-audit determination,
again denying Ms. Zaffran'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 Ms. Zaffran's claim should be paid.

On

April 28, 2006, we issued an Order to show cause and referred the
matter to the Special Master for further proceedings.

See PTO

No. 6223 (Apr. 28, 2006).
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 July 28, 2006.

Under the

Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor8 to review claims after the Trust and

8. 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
(continued...)
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claimant have had the opportunity to develop the Show Cause
Record.

See Audit Rule 30.

The Special Master assigned a

Technical Advisor, James F. Burke, 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 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).

8. (...continued)
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-

In support of her claim, Ms. Zaffran reasserts the
arguments that she made in contest, namely, that there is a
reasonable medical basis for Dr. Ansari's Green Form
representation that claimant had moderate mitral regurgitation.
In response, the Trust argues that Dr. Ansari's letter
does not provide a reasonable medical basis for his Green Form
representation because "the measurements upon which Dr. Ansari
relies are neither reliable nor representative."

The Trust

contends that these measurements were taken from very early
systole near the QRS complex, consistent with backflow, and are
"overtraced to include non-regurgitant flow and [are], in any
event, not seen in [claimant's] real-time echocardiogram study."
The Trust further contends that "the LAA measurement upon which
Dr. Ansari relies was taken during early systole, when the left
atrium is at its smallest, resulting in a marked underestimation
of Respondent's true LAA and, in turn, further exaggeration of
Respondent's supposed RJA/LAA ratio."
The Technical Advisor, Dr. Burke, reviewed claimant's
echocardiogram and concluded that there was a reasonable medical
basis for the attesting physician's finding that claimant had
moderate mitral regurgitation.

Specifically, Dr. Burke

determined that:
... I found the planimetered areas on the
tape representative of those noted in realtime. The planimetered areas were reasonably
done. They specifically excluded backflow.
-7-

The left atrial planimetered area measurement
also appeared to be done correctly and
probably from the same frame as the RJA
(regurgitant jet area) measurement.
....
Using representative beats in the apical four
chamber view, I calculated the RJA/LAA ratios
to range from 22% to 47%. These ratios are
in the range for moderate to severe mitral
regurgitation.
Using representative beats in the apical
three chamber view, calculated the RJA/LAA
ratios to range from 25% to 36%. This
represents moderate mitral regurgitation.
After reviewing the entire Show Cause Record, we find
that claimant has established a reasonable medical basis for her
claim.

Claimant's attesting physician, Dr. Ansari, reviewed

claimant's echocardiogram and found that claimant had moderate
mitral regurgitation.

Without adequate support, the Trust

challenged the attesting physician's finding and argued that his
measurements were not reliable or representative.

Dr. Burke,

however, reviewed claimant's echocardiogram and determined that
Ms. Zaffran's RJA/LAA ratio in the apical four chamber view
ranged from 22% to 47% and in the apical three chamber view
ranged from 25% to 36%.

In addition, Dr. Burke specifically

determined that Dr. Ansari's measurements were representative,
not overtraced, and did not include backflow.9

9. Despite an opportunity to do so, the Trust did not submit a
response to the Technical Advisor Report. See Audit Rule 34.
-8-

For the foregoing reasons, we conclude that claimant
has met her burden of proving that there is a reasonable medical
basis for her claim and is consequently entitled to Matrix A-1,
Level II benefits.

Therefore, we will reverse the Trust's denial

of Ms. Zaffran's claim for Matrix Benefits and the related
derivative claim submitted by her spouse.

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