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

Filing 4839

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9096 RE: CLAIMANT PAMELA MATLOCK. SIGNED BY HONORABLE HARVEY BARTLE, III ON 6/25/2013; 6/26/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE 11-MD-1203 PAPER NO.110041) (kk, )

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: DIET DRUGS (PHENTERMINE/
FENFLURAMINE/DEXFENFLURAMINE)
PRODUCTS LIABILITY LITIGATION

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THIS DOCUMENT RELATES TO:

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MDL NO. 1203

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SHEILA BROWN, et al.

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v.

CIVIL ACTION NO. 99-20593

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AMERICAN HOME PRODUCTS
CORPORATION

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2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER

June ~S: 2013

Bartle, J.

Pamela Matlock ("Ms. Matlock" 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.
In 2009, Pfizer, Inc. acquired Wyeth.
2. Wayne Matlock, Ms. Matlock's spouse, also has submitted a
derivative claim for benefits.
3. 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
(continued ... )

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To seek Matrix Benefits, a claimant must 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 November, 2008, claimant submitted a completed
supplemental Green Form to the Trust signed by her attesting
physician, Wassim H. Shaheen, M.D.

Based on a February 28, 2008

echocardiogram, 4 Dr. Shaheen attested in Part II of Ms. Matlock's
Green Form that she suffered from moderate aortic regurgitation
and had surgery to repair or replace the aortic and/or mitral

3.
( ... continued)
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.
4.
Because claimant's February 28, 2008 echocardiogram was
performed after the end of the Screening Period, claimant relied
on an echocardiogram dated April 24, 2002 to establish her
eligibility to receive Matrix Benefits.
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valve(s) following the use of Pondimin® and/or Redux™. 5

Based on

such findings, claimant would be entitled to Matrix A-1, Level
III benefits in the amount of $645,047. 6
Dr. Shaheen also attested that claimant suffered from
aortic stenosis.

Under the Settlement Agreement, the presence of

aortic stenosis, which is defined as "[a]ortic stenosis with an
aortic valve area < 1.0 square centimeter by the Continuity
Equation," requires the payment of reduced Matrix Benefits.
Settlement Agreement

§

IV.B.2.d. (2) (c)i)e).

In addition,

Dr. Shaheen attested that claimant did not have aortic sclerosis
at the time she was first diagnosed with mild or greater aortic
regurgitation.

Under the Settlement Agreement, the presence of

aortic sclerosis in claimants who were sixty (60) years of age or
older at the time they were first diagnosed as FDA Positive 7 also
requires the payment of reduced Matrix Benefits.

As the Trust

does not contest Ms. Matlock's entitlement to Level III benefits,
the only issue before us is whether claimant is entitled to
payment on Matrix A-1 or Matrix B-1.
5.
In addition, Dr. Shaheen attested that claimant suffered from
mild mitral regurgitation, an abnormal left atrial dimension, and
New York Heart Association Functional Class II Symptoms. These
conditions are not at issue in this claim.
6. Under the Settlement Agreement, a claimant is entitled to
Level III benefits if he or she suffers from "left sided valvular
heart disease requiring ... [s]urgery to repair or replace the
aortic and/or mitral valve(s) following the use of Pondimin®
and/or Redux™." See Settlement Agreement § IV.B.2.c. (3) (a).
7.
FDA Positive is defined, in pertinent part, as "mild or
greater regurgitation of the aortic valve." Settlement Agreement
§ I.22.a.
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In April, 2009, the Trust forwarded the claim for
review by M. Michele Penkala, M.D., one of its auditing
cardiologists.

In audit, Dr. Penkala concluded that there was a

reasonable medical basis for the attesting physician's finding
that claimant had aortic stenosis with an aortic valve area < 1.0
square centimeter by the Continuity Equation based on claimant's
February 28, 2008 echocardiogram.

Dr. Penkala also determined

that there was no reasonable medical basis for Dr. Shaheen's
representation that Ms. Matlock did not have aortic sclerosis at
the time she was first diagnosed with mild or greater aortic
regurgitation, which occurred when she was sixty (60) years of
age or older.

Dr. Penkala explained, in pertinent part, that:

To me the 2D appearance of the [aortic valve]
on the [echocardiogram] study [of] 4/24/02 is
consistent [with] [aortic valve] sclerosis (mild leaflet thickening + calcification)
without stenosis. Although the peak velocity
across the [aortic valve] (and the x/peak
gradients) are slightly higher than usually
seen [with] [aortic valve] sclerosis this
most likely is due to the [increased] flow
across the aortic valve due to moderate
[aortic insufficiency] . The claimant was 60
years old at the time of this
[echocardiogram] study.
Based on the auditing cardiologist's findings, the
Trust issued a post-audit determination that Ms. Matlock was
entitled only to Matrix B-1, Level III benefits.

Pursuant to the

Rules for the Audit of Matrix Compensation Claims ("Audit
Rules"), claimant contested this adverse determination. 8

8.

In

Claims placed into audit on or before December 1, 2002 are
(continued ... )
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contest, claimant argued that her claim only can be reduced if
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the sclerosis or calcification ... appeared at the time the

diagnosis of valvulopathy was first made[,] April 24, 2002.

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Thus, according to claimant, she should receive Matrix A-1
benefits because the auditing cardiologist did not find the
presence of aortic stenosis based on claimant's April 24, 2002
echocardiogram and the physician that reviewed her prior claim
under the Seventh Amendment did not find the presence of either
aortic sclerosis or aortic stenosis based on claimant's
April 24, 2002 echocardiogram.
The Trust then issued a final post-audit determination,
again determining that Ms. Matlock was entitled only to
Matrix B-1, Level III benefits.

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. Matlock's claim should be paid.

On

December 15, 2009, we issued an Order to show cause and referred
the matter to the Special Master for further proceedings.

See

PTO No. 8362 (Dec. 15, 2009).

8.
( ... continued)
governed by the Policies and Procedures for Audit and Disposition
of Matrix Compensation Claims in Audit, as approved in Pretrial
Order ( 11 PT0 11 ) 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. Matlock's claim.
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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 February 24, 2010.

The

Show Cause Record is now before the court for final
determination.

See Audit 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 finding that Ms. Matlock did not
have aortic sclerosis at the time she was first diagnosed with
mild or greater aortic regurgitation and aortic stenosis with an
aortic valve area < 1.0 square centimeter by the Continuity
Equation.

See id. Rule 24.

Ultimately, if we determine that

there is no reasonable medical basis for these findings, 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 these findings, 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, claimant reasserts the
arguments that she made during contest.

In addition, claimant

argues that the auditing cardiologist's determination is "a
different diagnosis based on speculation" because she only
stated,

"although the peak velocity across the [aortic valve] and

the x/peak gradients are slightly higher than usually seen with
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[aortic valve] sclerosis this most likely is due to increased
flow across the aortic valve due to moderate [aortic
insufficiency]."
In response, the Trust argues that Ms. Matlock failed
to demonstrate a reasonable medical basis for finding that her
April 24, 2002 echocardiogram did not demonstrate aortic
sclerosis because the Seventh Amendment reviewer did not review
her April 24, 2002 echocardiogram for this condition.

In

addition, the Trust contends that claimant's request for "a
temporal coincidence of FDA positive diagnosis and diagnosis of
aortic sclerosis and/or aortic stenosis" as a prerequisite to
application of these specific reduction factors is not supported
by the relevant language of the Settlement Agreement.
After reviewing the entire Show Cause Record, we find
claimant's arguments are without merit.

As an initial matter,

claimant does not adequately challenge the findings of the
auditing cardiologist with respect to the existence of aortic
sclerosis or aortic stenosis.

Claimant does not challenge at all

the existence of aortic stenosis on her February 28, 2008
echocardiogram,

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and her only challenge to the presence of aortic

sclerosis is that such finding is inconsistent with the results
of her Seventh Amendment review.

Contrary to claimant's

assertion, however, the Seventh Amendment reviewer did not

9. The report of claimant's February 28, 2008 echocardiogram
states, "There is at least moderate aortic stenosis with a mean
gradient of 34 mm.
The calculated valve area is 0.9 cm 2 . "
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determine that Ms. Matlock's April 24, 2002 echocardiogram did
not demonstrate aortic sclerosis.

In fact,

the report of that

review specifically states, with respect to aortic stenosis,
aortic sclerosis, and other specific medical conditions:
No values are reported for these measurements
because the Participating Physician who read
this Relevant Echocardiogram found that the
Aortic Valve did not meet the minimum Degree
of Regurgitation threshold required by the
terms of the Seventh Amendment for the Claim
to be one that could qualify for benefits
Subject to Medical Review.
Mere disagreement with the auditing cardiologist without
identifying any specific error by her is insufficient to meet a
claimant's burden of proof.
We also disagree with Ms. Matlock that the reduction
factor of aortic stenosis only applies when it is diagnosed at
the time the requisite level of valvular regurgitation is found
to exist.

Although the parties considered temporal limitations

in connection with certain reduction factors, nothing in the
Settlement Agreement provides for a temporal limitation for the
reduction factor of aortic stenosis.
Agreement § IV.B.2.d. (2) (c)i)e)

Compare Settlement

("Aortic stenosis with an aortic

valve area < 1.0 square centimeter by the Continuity Equation")
with Settlement Agreement§ IV.B.2.d. (2) (c)iii)b)

("Bacterial

endocarditis prior to Pondimin® and/or Redux™ use"); see also
Mem. in Supp. of PTO No. 8822, at 9-11 (Feb. 22, 2012), aff'd,

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No. 12-3138, 2013 WL 2166119, at *2-3 (May 21, 2013) . 10
apply the Settlement Agreement as written.

We must

As claimant does not

contest that she has aortic stenosis as defined by the Settlement
Agreement, the Settlement Agreement mandates that her claim be
reduced to Matrix B-1.
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 did not have aortic sclerosis
and aortic stenosis.

Therefore, we will affirm the Trust's

denial of Ms. Matlock's claim for Matrix A, Level III benefits
and the derivative claim submitted by her spouse.

10. Although the reduction factor of aortic sclerosis only
applies if claimant is sixty (60) years of age or older at the
time he or she is first diagnosed as FDA Positive, see Settlement
Agreement§ IV.B.2.d. (2) (c)i)c), claimant does not contest this
application.
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