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

Filing 4942

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9165 RE: CLAIMANT BEVERLY A. ELLIS. SIGNED BY HONORABLE HARVEY BARTLE, III ON 11/20/2013; 11/20/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110147 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

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.qJ{?5

November~O,

Bartle, J.

2013

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

1

seeks benefits

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.
In 2009, Pfizer, Inc. acquired Wyeth.
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 October, 2010, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Paul W.
Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A.

Based on an

echocardiogram dated April 22, 2002, 3 Dr. Dlabal attested in
Part II of claimant's Green Form that Ms. Ellis suffered from
moderate aortic regurgitation and had surgery to repair or
replace the aortic and/or mitral valve(s) following the use of

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.
Claimant's Green Form relies on an echocardiogram dated
April 22, 2002. The Show Cause Record, however, contains an
echocardiogram report dated April 20, 2002.
The parties do not
dispute that the echocardiogram report dated April 20, 2002 is
the report of claimant's April 22, 2002 echocardiogram.
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Pondimin® and/or Redux™. 4

Based on such findings, claimant would

be entitled to Matrix A-1, Level III benefits in the amount of
$335,553. 5
In the report of claimant's echocardiogram, the
reviewing cardiologist, B. Shields Stutts, M.D., F.A.C.C. stated,
"There is calcific aortic stenosis, which is mild to moderate."
Dr. Stutts measured claimant's aortic valve area to be 1.39 cm 2 •
Dr. Dlabal attested in claimant's Green Form that Ms. Ellis did
not suffer from aortic stenosis. 6

Under the Settlement

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

§

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

Settlement

As the Trust does not contest

claimant's entitlement to Level III benefits, the only issue

4. Dr. Dlabal also attested that claimant suffered from mild
mitral regurgitation, an abnormal left atrial dimension, a
reduced ejection fraction in the range of 50% to 60%, and New
York Heart Association Functional Class III symptoms. These
conditions are not at issue in this claim.
5. 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™." Settlement Agreement § IV.B.2.c. (3) (a).
6.
In addition, Dr. Dlabal attested that claimant did not suffer
from aortic sclerosis. The Trust disputes this representation.
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 also requires the
payment of reduced Matrix Benefits.
See id.
§ IV.B.2.d. (2) (c)i)c).
Given our disposition with respect to
whether claimant has aortic stenosis, we need not determine this
dispute.
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before us is whether claimant is entitled to payment on
Matrix A-1 or Matrix B-1.
In December, 2010, the Trust forwarded the claim for
review by Robert L. Gillespie, M.D., F.A.C.C., F.A.S.E., one of
its auditing cardiologists.

In audit, Dr. Gillespie concluded

that there was no reasonable medical basis for Dr. Dlabal's
finding that claimant did not have aortic stenosis with an aortic
valve area less than 1.0 square centimeter by the Continuity
Equation.

In support of this conclusion, Dr. Gillespie stated,

"The aortic valve on 4/22/02 had mild [aortic stenosis] and the
subsequent studies on 8/28/09 and 9/4/09 had severe [aortic
stenosis] .

The [aortic valve area] was not less than 1 cm2 on

the first

[echocardiogram] but was on the 2 subsequent studies."
Based on Dr. Gillespie's finding,

the Trust issued a

post-audit determination that Ms. Ellis 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. 7

In contest, claimant

argued that there was a reasonable medical basis for Dr. Dlabal's
representation that Ms. Ellis had aortic stenosis because the
aortic stenosis on her April 22, 2002 echocardiogram was

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 this
claim.
-4-

"insufficient to reduce the claim."

According to Ms. Ellis, the

Trust is not permitted to rely upon more recent echocardiograms
in determining whether to apply a reduction factor because the
Settlement Agreement requires that the requisite level of aortic
stenosis be present on the echocardiogram that forms the basis
for her claim, here, claimant's April 22, 2002 echocardiogram. 8
Although not required to do so, the Trust forwarded the
claim for a second review by the auditing cardiologist.
Dr. Gillespie submitted a declaration in which he again concluded
that there was no reasonable medical basis for the attesting
physician's finding that Ms. Ellis did not have aortic stenosis
as defined by the Settlement Agreement.

Dr. Gillespie stated, in

relevant part:
As I stated at audit, Claimant had mild to
moderate aortic stenosis at the time of the
4/22/02 echocardiogram. At that time the
aortic valve was stenotic, but the [aortic
valve area] was not less than lcm 2 • However,
the studies dated 8/28/09 and 9/4/09,
performed shortly before Claimant's 9/15/09
aortic valve surgery, show severe aortic
stenosis with an aortic valve area less than
lcm 2 • Therefore, based upon all of the
medical records available for review, there
is no reasonable medical basis to conclude
that Claimant did not have aortic stenosis
with an [aortic valve area] less than lcm 2 •

8. Claimant also requested any instructions or directives given
to the auditing cardiologist by the Trust because she contends
the auditing cardiologist was not independent as required by the
Settlement Agreement. As there is no evidence the auditing
cardiologist did not perform an independent review of this claim,
we reject this argument.
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The Trust then issued a final post-audit determination,
again determining that Ms. Ellis was entitled only to
Level III benefits.

Ma~rix

B-1,

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 this claim should be paid.

On August 16, 2011, we issued an

Order to show cause and referred the matter to the Special Master
for further proceedings.

See PTO No. 8666 (Aug. 16, 2011).

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 January 11, 2012:, and

claimant submitted a sur-reply on February 7, 2012.

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.

See Audit Rule 30.

The Special Master assigned a

Technical Advisor, Gary J. Vigilante, M.D., F.A.C.C., to review
the documents submitted by the Trust and claimant and to prepare

9. 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
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.
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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
reasonable medical basis for the attesting physician's finding
that Ms. Ellis 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.
Rule 38(a).

See id.

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, Ms. Ellis reasserts the
arguments made in contest.

In addition, claimant contends that

the Settlement Agreement and other related documents provide that
the Trust's review is limited only to one echocardiogram.
Finally, Ms. Ellis argues that while Dr. Gillespie stated that
her echocardiograms dated August 28, 2009 and September 4, 2009
reveal aortic stenosis with an aortic valve area less than 1.0
square centimeter, he did not state that this determination was
made by using the Continuity Equation as required by the
Settlement Agreement.
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------------------------------------

In response, the Trust counters that claimant did not
establish a reasonable medical basis for Dr. Dlabal's
representations that claimant did not have aortic stenosis as
defined by the Settlement Agreement.

In addition, the Trust

asserts that there is no temporal limitation for finding the
presence of the reduction factors of aortic stenosis or aortic
sclerosis.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's echocardiograms and concluded that there was no
reasonable medical basis for the attesting physician's finding
that claimant did not have aortic stenosis.

Specifically,

Dr. Vigilante explained:
The CD of the transthoracic echocardiogram on
September 4, 2009 was reviewed ....
Pulse
wave and continuous wave dopplers in the left
ventricular outflow tract and through the
aortic valve were reviewed. The LVOT was
1.8 cm in diameter. Therefore, the left
ventricular outflow tract area was 2.54 cm2.
The mean velocity in the left ventricular
outflow tract was 0.50 meters per second.
The mean velocity through the aortic valve
was 3.56 meters per second. Therefore, the
aortic valve area calculated via the
Continuity Equation was 0.36 cm2.

[T]here is no reasonable medical basis
for the Attesting Physician's answer to Green
Form Question D.S.
That is, the Claimant had
obvious aortic stenosis with an aortic valve
area significantly less than 1.0 cm2 by the
Continuity Equation on the echocardiographic
study of September 4, 2009. An
echocardiographer could not reasonably
conclude that this study did not show aortic
stenosis with an aortic valve area of less

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than 1.0 cm2 by the Continuity Equation even
taking into account inter-reader variability.
In response to the Technical Advisor Report, Ms. Ellis
argues that she is entitled to Matrix A-1 benefits because the
Technical Advisor did not find an aortic valve area less than
1.0 square centimeter by the Continuity Equation using claimant's
April 22, 2002 echocardiogram. 10
After reviewing the entire Show Cause Record, we find
that claimant has failed to meet her burden of demonstrating that
she is entitled to Matrix A-1 benefits.

The Settlement Agreement

requires that a claim for benefits based on damage to the aortic
valve be reduced to Matrix B-1 if claimant had aortic stenosis
with an aortic valve area less than 1.0 square centimeter by the
Continuity Equation.
§

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

See Settlement Agreement
Here, the Technical Advisor and the

10. Claimant initially included with her response to the
Technical Advisor Report a supplemental declaration by
Dr. Dlabal.
Pursuant to Audit Rule 34, the Special Master
advised Ms. Ellis that Dr. Dlabal's supplemental declaration
could not become part of the Show Cause Record. Thereafter,
claimant filed "objections" to the decision denying the inclusion
of Dr. Dlabal's supplemental declaration in the Show Cause
Record. According to claimant, in his supplemental declaration,
Dr. Dlabal disputed the Technical Advisor's finding of aortic
sclerosis on claimant's April 22, 2002 echocardiogram.
Pursuant
to Audit Rule 34, there is no procedure by which Dr. Dlabal's
supplemental declaration can become part of the Show Cause
Record.
See Mem. in Supp. of PTO No. 9041, at 9 n.11
(Apr. 5, 2013); Mem. in Supp. of PTO No. 8402, at 12 n.13
(Feb. 22, 2010).
In any event, the supplemental declara~ion of
Dr. Dlabal is irrelevant to the resolution of Ms. Ellis's claim
because his substantive challenges concern only the issue of
aortic sclerosis.
For all of these reasons, we will overrule
claimant's objections.
-9-

auditing cardiologist found that claimant's aortic valve area was
less than 1.0 square centimeter using her September 4, 2009
echocardiogram.

Specifically, Dr. Vigilante found that "the

aortic valve area calculated via the Continuity Equation was
0.36 cm2."

Dr. Gillespie also found that claimant's aortic valve

area on her September 4, 2009 echocardiogram was "less than
1 cm 2

."

Significantly, none of claimant's physicians disputes
that her September 4, 2009 echocardiogram shows the presence of
aortic stenosis with an aortic valve area less than 1.0 square
centimeter by the Continuity Equation.

Instead, Ms. Ellis argues

that this later echocardiogram should be disregarded because,
according to claimant, the reduction factors set forth in the
Settlement Agreement, such as aortic stenosis, have a temporal
limitation.

We recently rejected this argument, holding that

"[t]o avoid receiving reduced Matrix Benefits, claimant must
demonstrate, at a minimum, that she did not suffer from a
reduction factor at the time she suffered from the conditions
supporting her supplemental claim."

See Mem. in Supp. of PTO

No. 8822, at 9 (Feb. 22, 2012), aff 'd, In re: Diet Drugs
(Phentermine/Fenfluramine/Dexfenfluramine) Prods. Liab. Litig.,
No. 12-3138, 2013 WL 2166119 (3d Cir. Oct. 9, 2012); see also
Mem. in Supp. of PTO No. 8743, at 2-7 (Dec. 27, 2011).

As

claimant does not dispute the presence of aortic stenosis as
defined by the Settlement Agreement on her September 4, 2009
echocardiogram, which was performed prior to September 15, 2009,
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the date of her aortic valve surgery, the Settlement Agreement
requires that her Level III 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 stenosis
with an aortic valve area less than 1.0 square centimeter by the
Continuity Equation.

Therefore, we will affirm the Trust's

denial of the claim of Ms. Ellis for Matrix A, Level III
benefits.

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