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

Filing 4742

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9052 RE: CLAIMANT KIM L. SCHEPP. SIGNED BY HONORABLE HARVEY BARTLE, III ON 4/30/2013; 4/30/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE 11-MD-1203 PAPER NO.109958) (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.
April

Bartle, J.

30,

2013

Kim L. Schepp ("Ms. Schepp" 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").

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 "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
(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 January, 2012, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Azam
Ansari, M.D., F.A.H.A.

u.

Based on an echocardiogram dated

March 28, 2011, Dr. Ansari attested in Part II of Ms. Schepp's
Green Form that claimant suffered from mild aortic regurgitation
and had surgery to repair or replace the aortic and/or mitral
valve(s) following the use of Pondimin® and/or Redux™. 3

Based on

2.
( ... continued)
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.
3. Dr. Ansari also attested that claimant suffered from mild
mitral regurgitation and New York Heart Association Functional
Class III symptoms.
These conditions are not at issue in this
claim.
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such findings, claimant would be entitled to Matrix A-1,
Level III benefits in the amount of $859,612. 4
Dr. Ansari also attested in claimant's Green Form that
Ms. Schepp did not suffer 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.
§ IV.B.2.d. (2) (c)i)e).

Settlement Agreement

As the Trust does not contest

Ms. Schepp'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.
In February, 2012, 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 did not have aortic
stenosis with an aortic valve area < 1.0 square centimeter by the
Continuity Equation.

In support of this conclusion, Dr. Bier

stated:
The aortic valve is clearly stenotic.
The
Doppler data required to quantitate the
severity is not included on the disc.
The
following day, 3/29/11, the patient underwent
catheterization to clarify the severity of
the aortic stenosis and the valve area was

4.
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).
-3-

found to be
the patient
replacement
is no [sic]
significant
totality of

0.9 sq. em (severe). On 3/30/11
underwent aortic valve
for severe aortic stenosis.
It
reasonable to claim there is no
aortic stenosis given the
the information. 5

Based on the auditing cardiologist's findings,

the

Trust issued a post-audit determination that Ms. Schepp 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. 6

In

contest, claimant argued that she was entitled to Matrix A-1
level benefits because Dr. Bier used a "totality of information"
standard for determining the presence of aortic stenosis rather
than the Continuity Equation, the method required by the
Settlement Agreement.

Claimant also submitted a statement from

5. As part of his audit, Dr. Bier also reviewed a
November 14, 2002 echocardiogram that claimant submitted with a
Gray Form in December, 2002.
The Gray Form is the form under the
Settlement Agreement used to report the results of an
echocardiogram that is relied upon by a claimant to establish her
eligibility for Matrix Benefits.
See Settlement Agreement
§ VI.C.2.e.-f.
In reviewing this echocardiogram, Dr. Bier agreed
that there was a reasonable medical basis for finding that
claimant did not have aortic stenosis with an aortic valve area
< 1.0 square centimeter by the Continuity Equation.
In the
Attestation of Auditing Cardiologist, Dr. Bier stated, in
relevant part, "There is no significant stenosis on the study
from 1/14/02[.]"
6.
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. Schepp's claim.
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her attesting physician.

Dr. Ansari concluded, in relevant part,

that:
Dr. Bier and the Trust created an unwarranted
conflict by substituting the hydraulic
equation at cardiac catherization [sic] to
calculate [aortic valve area] . The Trust
adopted a modality and methodology that is
precluded and not permitted according to the
terms of the Settlement Agreement and the
Green Form, supra.
The [aortic valve area]
measurement of < 1.0 cm2 , which was measured
by hydraulic equation in the U of M cardiac
catherization [sic] laboratory, is not the
mandated methodology or modality established
in the terms of the Settlement Agreement or
the Green Form, and it is inadmissible
according to the Court approved Settlement
Agreement, the Official Notice of Final
Judicial Approval of the Settlement
Agreement, and the Green Form.
The correct
modality and methodology for determining
[aortic valve area] is calculation of [aortic
valve area] by Continuity Equation by [two
dimensional transthoracic echocardiogram] and
Doppler as shown in the qualifying [two
dimensional transthoracic echocardiogram] of
November 14, 2202 [sic] and the attestation
[two dimensional transthoracic
echocardiogram] of March 28, 2011.
In
Ms. Schepp's medical records, there are four
[aortic valve area] measurement[s] that are
> 1.0 cm 2 that meet the mandates and are
shown in both the qualifying and the
attestation [two dimensional transthoracic
echocardiograms] and Dopplers, supra.
(footnote omitted).
Although not required to do so, the Trust forwarded the
claim to the auditing cardiologist for a second review.

Dr. Bier

submitted a declaration in which he confirmed his previous
conclusion that there was no reasonable medical basis for
Dr. Ansari's finding that claimant did not have aortic stenosis.
Specifically, Dr. Bier stated, in relevant part:
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10.

Based on my review, I confirm my finding
at audit, that there is no reasonable
medical basis for the Attesting
Physician's representation that Claimant
did not have Aortic Stenosis. At
Contest, I reviewed the March 28, 2011
echocardiogram, which included Doppler
tracings.
I agree that this echo does
not show severe Aortic Stenosis (i.e.,
Aortic Stenosis with an aortic valve
area < 1cm 2 ) .
However, taking into
consideration all of the medical records
and documentation submitted in support
of the Claim, it is apparent that
Claimant had severe Aortic Stenosis at
the time of her March 31, 2011 surgery
and there is no reasonable medical basis
to conclude otherwise.

11.

The following medical records and
documentation informed my conclusion
that Claimant had Aortic Stenosis with
an aortic valve area< 1cm 2 :

12.

Claimant's [transesophageal
echocardiogram] of 3/1/11 was
interpreted as showing severe [aortic
stenosis] (<1.0).
See March 1, 2011
[transesophageal echocardiogram] Report
("The aortic valve ... was found to have
an aortic valve area of 0.7 via 2D and
0.83 cm2 on the 3-dimensional.")

13.

While Claimant's March 1, 2011 Cardiac
Catheterization report indicates aortic
valve areas of 1.0cm2 and 1.5cm2, it is
noted on the report that these
measurements are unreliable.
See
March 1, 2011 [transesophageal
echocardiogram] Report ("Probable severe
aortic stenosis as patient's cardiac
output was likely over estimated by the
thermal dilution method ... ")

14.

Two days after the March 28, 2011
Echocardiogram of Attestation, on
March 30, 2011, Claimant underwent a
Cardiac Catheterization which shows
severe Aortic Stenosis.

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15.

Claimant's March 31, 2011 surgery was
performed for severe, symptomatic aortic
Stenosis, as noted in the History &
Physical and the Operative Report.
See
March 28, 2011 Consultation (" ...
diagnosed with severe aortic stenosis,")
and March 31, 2011 Operative Report.

16.

Accordingly, I affirm my findings at
audit, that there is no reasonable
medical basis for a finding that
Claimant did not have Aortic Stenosis.

The Trust then issued a final post-audit determination,
again determining that Ms. Schepp 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. Schepp's claim should be paid.

On

November 8, 2012, we issued an Order to show cause and referred
the matter to the Special Master for further proceedings.

See

PTO No. 8959 (Nov. 8, 2012).
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 19, 2013, and

claimant submitted a sur-reply on March 6, 2013.

The Show Cause

Record is now before the court for final determination.
Audit Rule 35.

-7-

See

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 the attesting physician's finding
that Ms. Schepp did not have aortic stenosis with an aortic valve
area < 1.0 square centimeter by the Continuity Equation.
Rule 24.

See id.

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.
38{a).

See id. Rule

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).

In support of her claim, claimant reasserts the
arguments that she made during contest.

In response, the Trust

argues that the claim properly was reduced to the B-1 Matrix
because, "given the totality of the claim," Ms. Schepp had severe
aortic stenosis prior to her aortic valve replacement surgery.
In her sur-reply, claimant argues that the Trust's definition of
aortic stenosis and use of a "totality of information" standard
to determine the presence of aortic stenosis is contrary to the
terms of the Settlement Agreement.
After reviewing the entire Show Cause Record, we find
that claimant has established a reasonable medical basis for her
attesting physician's representation that Ms. Schepp did not have
aortic stenosis.

In connection with the audit of Ms. Schepp's
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claim, the Trust's auditing cardiologist reviewed claimant's
echocardiograms dated November 14, 2002 and March 28, 2011. 7

In

both instances, the auditing cardiologist concluded that claimant
did not have aortic stenosis with an aortic valve area < 1.0
square centimeter by the Continuity Equation.
As to claimant's March 28, 2011 echocardiogram, the
Trust's auditing cardiologist stated,

"I agree that this

[echocardiogram] does not show severe Aortic Stenosis (i.e.
Aortic Stenosis with an aortic valve area< 1cm 2 )

."

As to

claimant's November 14, 2012 echocardiogram, Dr. Bier concluded
that there was a reasonable medical basis for finding that
claimant did not have an aortic valve area < 1.0 square
centimeter.
The Trust argues that an auditing cardiologist may
determine that a representation by an attesting physician that a
claimant has aortic stenosis with an aortic valve area < 1.0
square centimeter by the Continuity Equation is without a
reasonable medical basis by reference to aortic valve area
calculations made using methods other than the Continuity
Equation and medical records documenting "aortic stenosis," even
when the auditing cardiologist has reviewed that claimant's

7. The auditing cardiologist also reviewed claimant's
February 14, 2007 echocardiogram, but he did not make a finding
as to aortic stenosis.
The report for this echocardiogram,
however, states that the echocardiogram demonstrated an "aortic
valve area of 1.4." Notably, the Trust does not dispute the
opinion of the attesting physician that this calculation was
performed using the Continuity Equation.
-9-

echocardiograms and determined that they do not demonstrate
aortic stenosis with an aortic valve area< 1.0 square centimeter
by the Continuity Equation.

We disagree.

In PTO No. 9009 (Feb. 26, 2013), we rejected a similar
argument raised by the Trust.

As we stated,

"We reject the

Trust's assertion that it may find the presence of aortic
stenosis from the 'totality' of claimant's medical evidence
rather than based on a measurement of claimant's aortic valve
area by the Continuity Equation."

Id. at 8.

In reaching this

conclusion, we relied on our earlier decision in PTO No. 8562
(Nov. 15, 2010), where we rejected a similar argument raised by a
claimant who sought to negate a finding of aortic stenosis by
relying on evidence other than a measurement of his aortic valve
area by the Continuity Equation.
stated,

Id. at 12 n.11.

There, we

"We reject claimant's argument that he may disprove the

existence of aortic stenosis by a method other than the
Continuity Equation, which is specifically required by the
Settlement Agreement."
§

(citing Settlement Agreement

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

We must apply the Settlement Agreement as written.
the Trust concedes that claimant's echocardiograms do not
demonstrate aortic stenosis with an aortic valve area < 1.0
square centimeter by the Continuity Equation, the Settlement

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As

Agreement mandates that the present claim cannot be reduced to
Matrix B-1. 8
For the foregoing reasons, we conclude that claimant
has met her burden of proving that she does not have aortic
stenosis with an aortic valve area of
the Continuity Equation.

<

1.0 square centimeter by

Therefore, we will reverse the Trust's

denial of Ms. Schepp's claim for Matrix A-1, Level III benefits.

8. As the Trust notes, the auditing cardiologist's conclusion of
severe aortic stenosis was based on a March 1, 2011
transesophageal echocardiogram, March 1, 2011 and March 28, 2011
cardiac catheterizations, and a History & Physical and Operative
Report relating to claimant's aortic valve surgery.
The Trust
does not contend that any of these records reflects a finding of
aortic stenosis < 1.0 square centimeter by the Continuity
Equation. The Trust also does not dispute the opinion of the
attesting physician that any aortic valve area measurements
identified on these reports were not determined by the Continuity
Equation. Thus, the Trust's reliance on these records is
misplaced.
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