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

Filing 4826

MEMORANDUM IN SUPPORT OF PRETRIAL ORDER NO. 9090 RE: CLAIMANT LINDA A. SHELTON. SIGNED BY HONORABLE HARVEY BARTLE, III ON 6/19/2013; 6/19/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110029 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

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MDL NO. 1203

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CIVIL ACTION NO. 99-20593

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THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.

v.
AMERICAN HOME PRODUCTS
CORPORATION

2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

q090

June I 't

Bartle, J.

,

2013

Linda A. Shelton ("Ms. Shelton" 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.
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
serious VHD who took the drugs for 61 days or longer and who did
(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.
Under the Settlement Agreement, only eligible claimants
are entitled to Matrix Benefits.

Generally, a claimant is

considered to be eligible for Matrix Benefits if he or she is
diagnosed with mild or greater aortic and/or mitral regurgitation
by an echocardiogram performed between the commencement of Diet
Drug use and the end of the Screening Period. 3

See Settlement

Agreement §§ IV.B.l.a. & I.22.
In April, 2007, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Mohamad S.

2.
( ... continued)
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. See Settlement Agreement § IV.A.l.a. (Screening Program
established under the Settlement Agreement) .
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Martini, M.D.

Based on an echocardiogram dated June 23, 2006, 4

Dr. Martini attested in Part II of Ms. Shelton's Green Form that
claimant suffered from mild aortic regurgitation, congenital
aortic valve abnormalities, and aortic stenosis with an aortic
valve area < 1.0 square centimeters by the Continuity Equation
and that she had surgery to repair or replace the aortic and/or
mitral valve (s) following use of Pondimin® and/or Redux™. 5

Based

on such findings, claimant would be entitled to Matrix B-1,

6

Level III benefits in the amount of $150,888. 7
In November, 2008, 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 finding that

4. Because claimant's June 23, 2006 echocardiogram was performed
after the end of the Screening Period, claimant relied on an
echocardiogram dated December 23, 2002 to establish her
eligibility to Matrix Benefits.
5. Dr. Martini also attested that claimant suffered from mild
mitral regurgitation, a reduced ejection fraction in the range of
50% to 60%, and either New York Heart Association Functional
Class I or II symptoms. These conditions are not at issue in
this claim.
6. Under the Settlement Agreement the presence of congenital
aortic valve abnormalities or aortic stenosis requires the
payment of reduced Matrix Benefits. See Settlement Agreement
§ § IV . B . 2 . d . ( 2 ) ( c ) i ) a) & e ) .
7. 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). As
the Trust concedes that Ms. Shelton has met these requirements,
the only issue is whether she is eligible for benefits.
-3-

claimant's December 23, 2002 echocardiogram demonstrated mild
aortic regurgitation.

Specifically, Dr. Gillespie determined,

"Trace aortic regurgitation noted.
43 cm/s which was too low.

The Nyquist limit was set at

[Aortic regurgitation] was trace at

this setting. " 8
Based on Dr. Gillespie's finding that claimant did not
have at least mild aortic regurgitation, the Trust issued a
post-audit determination denying Ms. Shelton's claim.

Pursuant

to the Rules for the Audit of Matrix Compensation Claims ("Audit
Rules"), claimant contested this adverse determination. 9

In

contest, claimant submitted the reports of four echocardiograms
performed on November 16, 1998; November 10, 1999;
April 30, 2002; and January 2, 2003; each of which claimant noted
indicated that she suffered from mild aortic regurgitation.
Claimant contended these reports provided a reasonable medical
basis for finding that her December 23, 2002 echocardiogram

8. As noted in the Report of Auditing Cardiologist Opinions
Concerning Green Form Questions at Issue, trace aortic
regurgitation is present where the regurgitant jet height ("JH")
in the parasternal long-axis view (or in the apical long-axis
view, if the parasternal long-axis view is unavailable) is less
than ten percent (10%) of the left ventricular outflow tract
height ( "LVOTH") . "
9.
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. Shelton's claim.
-4-

demonstrated mild aortic regurgitation.

Claimant also noted that

two of these four echocardiograms were performed by physicians
who participated in the Trust's Screening Program.
The Trust then issued a final post-audit determination,
again denying Ms. Shelton'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. Shelton's claim should be paid.

On

April 22, 2009, we issued an Order to show cause and referred the
matter to the Special Master for further proceedings.

See PTO

No. 8155 (Apr. 22, 2009).
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 12, 2009, and

claimant submitted a sur-reply on July 6, 2009.

Under the Audit

Rules, it is within the Special Master's discretion to appoint a
Technical Advisor 10 to review claims after the Trust and claimant
have had the opportunity to develop the Show Cause Record.

See

10. 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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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 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 finding that claimant's
December 23, 2002 echocardiogram demonstrated mild aortic
regurgitation.

See id. Rule 24.

Ultimately, if we determine

that there is no reasonable medical basis for such finding, 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 such finding, 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. Shelton reasserts the

arguments she raised in contest.

In addition, she contends that

the auditing cardiologist and the Trust erred because neither
considered her additional echocardiograms performed before the
end of the Screening Period.
In response, the Trust argues that Dr. Gillespie
properly applied the reasonable medical basis standard.

In

addition, the Trust asserts that the claimant did not submit any
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materials that rebut Dr. Gillespie's findings at audit that the
December 23, 2002 echocardiogram demonstrated trace aortic
regurgitation or that the Nyquist setting was improperly low.
Finally, the Trust contends that the additional echocardiograms
claimant submitted do not rebut Dr. Gillespie's findings at
audit.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's December 23, 2002 echocardiogram and concluded that
there was no reasonable medical basis for finding that it
demonstrated at least mild aortic regurgitation.

Specifically,

Dr. Vigilante observed, in pertinent part, that:
Visually, only trace aortic
regurgitation was noted in the parasternal
long-axis view.
The aortic regurgitant jet
could be also viewed in the apical long-axis
view.
In this view, trace to mild aortic
regurgitation was suggested.
I digitized
those cardiac cycles in the parasternal long
axis view in which the aortic regurgitant jet
was best visualized.
I then measured the JH
and LVOTH with electronic calipers.
I
determined that the largest representative JH
was 0.2 em.
I determined that the LVOTH was
2.4 em. Therefore, the largest
representative JH/LVOTH ratio was less than
9%. This ratio did not reach 10% in any
cardiac cycle. Therefore, only trace aortic
regurgitation could be diagnosed in the
parasternal long-axis view on this study. A
couple of the cardiac cycles showed no
evidence of aortic regurgitation at all.
There was no sonographer measurement of the
JH on this study. The sonographer did
measure an LVOTH of 2.17 em. This
measurement was inaccurately small as the
distal point of the measurement did not reach
the posterior aspect of the left ventricular
outflow tract.

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An echocardiographer could not
reasonably conclude that mild aortic
regurgitation was present when making
quantitative measurements of the aortic
regurgitant jet in the parasternal long-axis
view . . . even taking into account
inter-reader variability. 11

In response to the Technical Advisor Report, claimant
argues "that the Technical Advisor chose to substitute his
independent analysis of the pertinent echocardiographic studies
rather than to consider whether under the entire record the
Attesting Physician's findings were medically reasonable."

In

addition, Ms. Shelton asserts that Dr. Vigilante failed to
consider the findings of mild aortic regurgitation noted in the
reports of her November 16, 1998 and November 10, 1999
echocardiograms.

Finally, claimant contends that there is a

reasonable medical basis for finding mild aortic regurgitation on
her December 23, 2002 echocardiogram because Dr. Vigilante's
measurements are "very close" to the 10% threshold.
After reviewing the entire Show Cause Record, we find
claimant's arguments are without merit.

As an initial matter,

claimant does not adequately refute the findings of the auditing
cardiologist and Technical Advisor that there is no reasonable
medical basis for finding that her December 23, 2002
echocardiogram demonstrates mild aortic regurgitation.
Dr. Gillespie and Dr. Vigilante each determined that claimant's

11. Dr. Vigilante also reviewed the only other study in
claimant's record performed before the close of the Screening
Period, a study dated April 30, 2002, and concluded that it also
demonstrated only trace aortic regurgitation.
-8-

December 23, 2002 echocardiogram demonstrated only trace aortic
regurgitation.

Rather than respond to that specific finding,

claimant submitted the echocardiogram reports of four other
echocardiograms.

These echocardiogram reports, however, do not

provide an explanation for finding that claimant's
December 23, 2002 echocardiogram demonstrated mild aortic
regurgitation. 12

Mere disagreement with the auditing

cardiologist and the Technical Advisor without identifying
specific errors by them is insufficient to meet a claimant's
burden of proof.
We also disagree with claimant's interpretation of the
reasonable medical basis standard.

We are required to apply the

standards delineated in the Settlement Agreement and Audit Rules.
The context of those two documents leads us to interpret the
"reasonable medical basis" standard as more stringent than
claimant contends.

For example, as we previously explained in

PTO No. 2640, conduct "beyond the bounds of medical reason" can
include:

(1) failing to review multiple loops and still frames;

(2) failing to have a Board Certified Cardiologist properly
supervise and interpret the echocardiogram; (3) failing to
examine the regurgitant jet throughout a portion of systole;
(4) over-manipulating echocardiogram settings; (5) setting a low

12. Claimant indicated in a letter dated May 27, 2008 that
"[t]he echocardiogram that [she] wish[es] [the Trust] to use is
of 12-23-02." Contrary to her contention, it is the
reasonableness of finding mild aortic regurgitation on the basis
of this echocardiogram that is at issue in these proceedings.
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Nyquist limit;

(6) characterizing "artifacts," "phantom 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.

See

Mem. in Supp. of PTO No. 2640 at 9-13, 15, 21-22, 26
(Nov. 14, 2002).

Dr. Vigilante observed, and claimant did not

dispute, that the sonographer-measured LVOTH "was inaccurately
small as the distal point of the measurement did not reach the
posterior aspect of the left ventricular outflow tract. " 13

Such

an unacceptable practice cannot provide a reasonable medical
basis for the resulting diagnosis of mild aortic regurgitation.
To conclude otherwise would allow claimants who do not have mild
or greater aortic regurgitation to receive Matrix Benefits, which
would be contrary to the intent of the Settlement Agreement.
In addition, claimant's reliance on inter-reader
variability to establish a reasonable medical basis for the
attesting physician's representation that she had mild aortic
regurgitation is misplaced.

The concept of inter-reader

variability is already encompassed in the reasonable medical
basis standard applicable to claims under the Settlement
Agreement.

In this instance, a finding of mild aortic

regurgitation cannot be medically reasonable where the auditing
cardiologist and the Technical Advisor concluded, and claimant

13.
For this reason as well, we reject claimant's argument that
Dr. Vigilante simply substituted his opinion for that of the
reviewing cardiologist.
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.----------------------------------

did not adequately dispute, that Ms. Shelton's December 23, 2002
echocardiogram demonstrated at most trace aortic regurgitation.
Adopting claimant's argument regarding inter-reader variability
would allow a claimant who did not have the requisite level of
regurgitation to recover benefits and would render meaningless
this critical provision of the Settlement Agreement. 14
Finally, to the extent claimant argues that there is a
reasonable medical basis for finding mild aortic regurgitation
simply because a physician who participated in the Trust's
Screening Program also found mild aortic regurgitation on a
different echocardiogram, such argument is misplaced.

The

Settlement Agreement clearly provides that the sole benefit that
an eligible class member is entitled to receive based on an
echocardiogram performed in the Screening Program is a limited
amount of medical services or a limited cash payment:
All Diet Drug Recipients in Subclass 2(b) and
those Diet Drug Recipients in Subclass 1(b)
who have been diagnosed by a Qualified
Physician as FDA Positive by an
Echocardiogram performed between the
commencement of Diet Drug use and the end of
the Screening Period, will be entitled to
receive, at the Class Member's election,
either (i) valve-related medical services up
to $10,000 in value to be provided by the
Trust; or (ii) $6,000 in cash.

14. Moreover, the Technical Advisor took into account the
concept of inter-reader variability as reflected in his
statement, "An echocardiographer could not reasonably conclude
that mild aortic regurgitation was present when making
quantitative measurements of the aortic regurgitant jet in the
parasternal long-axis view in these studies even taking into
account inter-reader variability."
-11-

See Settlement Agreement § IV.A.1.c.

Thus, by the plain terms of

the Settlement Agreement, a Screening Program echocardiogram does
not automatically entitle a claimant to Matrix Benefits.
Indeed, this conclusion is confirmed by the Settlement
Agreement provisions concerning claimants eligible for Matrix
Benefits.

Specifically, claimants receiving a diagnosis of FDA

Positive or mild mitral regurgitation merely become eligible to
seek Matrix Benefits.

See id. § IV.B.1.

Further, adopting

claimant's position would be inconsistent with Section VI.E. of
the Settlement Agreement, which governs the audit of claims for
Matrix Benefits, as well as this Court's decision in PTO No. 2662
(Nov. 26, 2002), which mandates a 100% audit for all claims for
Matrix Benefits.

As nothing in the Settlement Agreement supports

the conclusion that a favorable Screening Program echocardiogram
for purposes of Fund A Benefits results in an immediate
entitlement to Matrix Benefits, we decline claimant's request to
interpret the Settlement Agreement in this fashion.
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 had mild aortic regurgitation
between the commencement of Diet Drug use and the end of the
Screening Period.

Therefore, we will affirm the Trust's denial

of Ms. Shelton's claim for Matrix B-1, Level III benefits.

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