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

Filing 4785

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9071 RE: CLAIMANT THE ESTATE OF RONALD J. BONZO. SIGNED BY HONORABLE HARVEY BARTLE, III ON 5/22/2013; 5/22/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109991 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

May d.:l.,

Bartle, J.

2013

The Estate of Ronald J. Bonzo ("Estate"), a
representative claimant under the Diet Drug Nationwide Class
Action Settlement Agreement ("Settlement Agreement") with Wyeth,
seeks benefits from the AHP Settlement Trust ("Trust"). 2

1

Based

on the record developed in the show cause process, we must
determine whether the Estate has demonstrated a reasonable
medical basis to support its claim for Matrix Compensation
Benefits ("Matrix Benefits") . 3

1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
2. Barbara Bonzo, Ronald J. Bonzo's ("Mr. Bonzo" or "decedent")
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 for
compensation purposes Diet Drug Recipients based upon the
(continued ... )

To seek Matrix Benefits, a representative claimant 4
must first submit a completed Green Form to the Trust.
Form consists of three parts.

The Green

The representative claimant

completes Part I of the Green Form.

Part II is completed by an

attesting physician, who must answer a series of questions
concerning the Diet Drug Recipient's medical conditions that
correlate to the Matrix criteria set forth in the Settlement
Agreement.

Finally, if the representative claimant is

represented by an attorney, the attorney must complete Part III.
In August, 2003, Faydra Hope, Representative of
Mr. Bonzo's estate, submitted a completed Green Form to the Trust
signed by decedent's attesting physician, Arthur Levene, M.D.
Based on an echocardiogram dated December 19, 1997, Dr. Levene
attested in Part II of the Green Form that Mr. Bonzo suffered

3.
( ... continued)
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 the Diet Drug Recipient'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 representative claimants where Diet
Drug Recipients are diagnosed with serious VHD, they took the
drugs for 61 days or longer, and they 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
representative claimants where the Diet Drug Recipients were
registered as having only mild mitral regurgitation by the close
of the Screening Period, they took the drugs for 60 days or less,
or they were diagnosed with conditions that would make it
difficult for them to prove that their VHD was caused solely by
the use of these Diet Drugs.
4. Under the Settlement Agreement, representative claimants
include estates, administrators or other legal representatives,
heirs or beneficiaries. See Settlement Agreement § II.B.
-2-

from moderate mitral regurgitation, mild aortic regurgitation, a
reduced ejection fraction in the range of 50% to 60%, death
resulting from a condition caused by valvular heart disease or
valvular repair/replacement surgery, and ventricular fibrillation
or sustained ventricular tachycardia resulting in hemodynamic
compromise.

Based on such findings, the Estate would be entitled

to Matrix A-1, Level V benefits in the amount of $1,378,155. 5
In the report of Mr. Bonzo's echocardiogram, the
reviewing cardiologist, Roger Fellows, M.D., observed that

5. Under the Settlement Agreement, a representative claimant is
entitled to Level V benefits if the Diet Drug Recipient:
(1) suffered death resulting from a condition caused by valvular
heart disease or valvular repair/replacement surgery which
occurred post-Pondimin® and/or Redux™ use as supported by a
statement from an attending Board-Certified Cardiothoracic
Surgeon or Board-Certified Cardiologist and medical records; or
(2) "otherwise qualifies for payment at Matrix Level II, III or
IV and suffers from ventricular fibrillation or sustained
ventricular tachycardia which results in hemodynamic compromise."
See Settlement Agreement§§ IV.B.2.c. (5) (c)-(d). A
representative claimant is entitled to Level II benefits for
damage to the mitral valve if the Diet Drug Recipient is
diagnosed with moderate or severe mitral regurgitation and one of
five complicating factors delineated in the Settlement Agreement.
See id. § IV.B.2.c. (2) (b). The Trust did not contest that
Mr. Bonzo suffered from mild aortic regurgitation; a reduced
ejection fraction, which is one of the complicating factors
needed to qualify for a Level II claim; or ventricular
fibrillation or sustained ventricular tachycardia resulting in
hemodynamic compromise. Thus, the Estate is entitled to Level V
benefits if Mr. Bonzo had at least moderate mitral regurgitation
or if he died as a result of a condition caused by valvular heart
disease or valvular repair/replacement surgery that occurred
post-Pondimin® and/or Redux™ use supported by a statement from an
attending Board-Certified Cardiothoracic Surgeon or
Board-Certified Cardiologist, supported by medical records.
-3-

Mr. Bonzo had "[t] ransient mitral regurgitation. " 6

Dr. Fellows,

however, did not specify a percentage as to the level of
decedent's mitral regurgitation.

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.

In February, 2006, the Trust forwarded the claim for
review by Waleed N. Irani, M.D., one of its auditing
cardiologists. 7

In audit, Dr. Irani concluded that there was no

reasonable medical basis for Dr. Levene's finding that the
decedent had moderate mitral regurgitation.

Specifically,

Dr. Irani stated that the "[e]cho report states trace [mitral
regurgitation] ." 8

In addition, Dr. Irani concluded that there

was no reasonable medical basis for Dr. Levene's finding that

6. Dr. Fellows also determined that decedent's echocardiogram
demonstrated "transient to mild aortic insufficiency."
7.
Pursuant to Pretrial Order ("PTO") No. 3882 (Aug. 26, 2004),
all Level III, Level IV, and Level V Matrix claims were subject
to the Parallel Processing Procedures ("PPP"). As Wyeth did not
agree that claimant had a Matrix A-1, Level v claim, the Trust
audited the Estate's claim pursuant to the PPP.
8. Dr. Irani relied on the report of Mr. Bonzo's
December 19, 1997 echocardiogram because claimant did not provide
the Trust with a copy of the echocardiogram tape.
Pursuant to
Section VI.C.2.e. of the Settlement Agreement, claimant submitted
an affidavit by Dr. Levene wherein he stated that, despite having
the original echocardiogram tape in his possession at the time he
completed the Green Form, he has since been unable to locate it.
Dr. Levene also stated that he reviewed the original
echocardiogram tape and concluded that it demonstrated that
Mr. Bonzo suffered from moderate mitral regurgitation.
-4-

Mr. Bonzo's death resulted from a condition caused by valvular
heart disease or valvular repair/replacement surgery.
explained, "Unable to accurately answer.

Dr. Irani

Given Echo report dated

12/19/97 [patient] did not have significant valvular heart
disease.

Out of hospital sudden death causes may include

arrhythmia- both tachycardia or bradycardia."
Based on the auditing cardiologist's findings and the
Estate's failure to submit a statement from Mr. Bonzo's attending
Board-Certified Cardiothoracic Surgeon or Board-Certified
Cardiologist, the Trust issued a post-audit determination denying
the Estate's claim.

Pursuant to the Rules for Audit of Matrix

Compensation Claims ("Audit Rules"), the Estate contested this
adverse determination. 9

In contest, the Estate argued that it

did not submit "a statement from the attending Board-Certified
Cardiothoracic Surgeon or Board-Certified Cardiologist" because
there was no Board-Certified Cardiothoracic Surgeon or
Board-Certified Cardiologist attending to Mr. Bonzo at the time
of his sudden death.

The Estate also asserted that its claim

could not be denied simply because the echocardiogram on which
the claim is based is missing since the Estate submitted an
affidavit of the person who last had custody of the

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 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 the Estate's claim.
-5-

echocardiogram tape as required by the Settlement Agreement.
Settlement Agreement

§§

See

VI.C.2.e.-f.

In addition, the Estate contended that there was a
reasonable medical basis for Dr. Levene's representation that
Mr. Bonzo had moderate mitral regurgitation.

In support, the

Estate submitted an affidavit from Dr. Levene wherein he stated,
in pertinent part, that:
Based upon my personal review of the original
echocardiogram tape of the echocardiogram
performed on Ronald J. Bonzo on
December 19, 1997, I determined that Ronald
Bonzo had moderate mitral regurgitation,
defined as regurgitant jet area in any apical
view equal to or greater than 20% of the left
atrial area but less than or equal to 40%
(20% to 40% RJA/LAA) .
The Estate also submitted a letter from Dr. Levene dated
May 15, 2006, wherein he stated, in pertinent part, that:
[T]he report [of Mr. Bonzo's echocardiogram]
is very vague, talking about transient
regurgitation, which is a bizarre term.
I am
not sure how that term was used. The
auditing cardiologist obviously could not
review the echocardiogram itself.
I
previously viewed the echocardiogram of
Mr. Bonzo on March 21, 2000. Since that time
it has gone missing. At that time we
determined [decedent] had evidence of mitral
regurgitation with a jet area of greater than
20% to left atrial size ....
I do understand
where the auditing cardiologist is coming
from in his report, but he is only basing it
on the report of the echocardiogram from
December 19, 1997, having never reviewed the
tape himself.
I was fortunate to have
reviewed that tape and made my determination
based on that. The progression and the
autopsy confirm that my diagnosis was more
likely correct.

-6-

The Estate asserted that Dr. Levene's conclusion that Mr. Bonzo
had moderate mitral regurgitation was corroborated by decedent's
Autopsy Report, which specifically concluded that one of the
causes of the decedent's death was "[m]itral valve insufficiency"
and that decedent's "mitral valve appears abnormal with one leaf
elongated."
The Trust then issued a final post-audit determination,
again denying the Estate's claim.

The Estate 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 the Estate's claim should be paid.

On

September 1, 2006, we issued an Order to show cause and referred
the matter to the Special Master for further proceedings.

See

PTO No. 6538 (Sept. 1, 2006).
Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
documentation.

The Estate then served a response upon the

Special Master.

The Trust submitted a reply on

December 21, 2006, and the Estate submitted a sur-reply on
February 2, 2007.

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 the Estate has met its burden of proving that there is a
reasonable medical basis for the attesting physician's findings
-7-

that Mr. Bonzo died as a result of a condition caused by VHD or
that Mr. Bonzo suffered from moderate mitral regurgitation.
id. Rule 24.

See

Ultimately, if we determine that there is no

reasonable medical basis for the answers in the Green Form that
are 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 answers, 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 its claim, the Estate raises the
arguments it raised in contest, namely, that there is a
reasonable medical basis for Dr. Levene's representation that
Mr. Bonzo had moderate mitral regurgitation and that it is not
required to submit a statement of an attending Board-Certified
Cardiothoracic Surgeon or Board-Certified Cardiologist because
Mr. Bonzo did not have an attending Board-Certified
Cardiothoracic Surgeon or Board-Certified Cardiologist at the
time of his death.

In addition, the Estate maintains that

Dr. Irani's responses at audit should be stricken and disregarded
because Dr. Irani did not comply with the Audit Rules.

According

to the Estate, Audit Rule 7(a) required the auditing cardiologist
to answer that the echocardiogram on which the Green Form
responses were based was "Not Evaluable" and, as a result, Audit
Rule 7(c) precluded Dr. Irani from offering an opinion as to the
reasonableness of Dr. Levene's representations.
-8-

Moreover, the

Estate argues that the Trust and Dr. Irani violated Audit Rule
23(b) because the Statement of the Case and Dr. Irani's
certification implies that Dr. Irani reviewed the echocardiogram
tape and made findings based on his review.
In response, the Trust argues that the Estate is not
entitled to Level V benefits because there is no reasonable
medical basis for the attesting physician's finding of moderate
mitral regurgitation and the Estate did not provide a statement
from an attending Board-Certified Cardiothoracic Surgeon or
Board-Certified Cardiologist stating that the decedent's death
resulted from a condition caused by VHD.

The Trust also asserts

that the Estate misinterprets the Settlement Agreement and Audit
Rules with regard to the auditing cardiologist's review.
Specifically, the Trust contends that the Section VI.C.4.b. of
the Settlement Agreement authorizes the auditing cardiologist to
consider other medical records to determine whether there is a
reasonable medical basis for Green Form representations based on
a missing echocardiogram.

Finally, the Trust submits that the

auditing cardiologist conducted the audit in accordance with the
Settlement Agreement and the Audit Rules.
After reviewing the entire Show Cause Record, we find
the Estate's arguments are without merit.

As an initial matter,

we reject the Estate's argument that it is not required to
provide a statement from an attending Board-Certified
Cardiothoracic Surgeon or Board-Certified Cardiologist.
Estate does not dispute that it has not submitted such a
-9-

The

statement.

Instead, the Estate argues that it should not be

required to submit such a statement because Mr. Bonzo did not
have an attending Board-Certified Cardiothoracic Surgeon or
Board-Certified Cardiologist at the time of his death.
disagree.

We

The Settlement Agreement specifically provides that an

eligible representative claimant is entitled to Level V benefits
if the Diet Drug Recipient suffered:
Death resulting from a condition caused by
valvular heart disease or valvular
repair/replacement surgery which occurred
post-Pondimin® and/or Redux™ use supported by
a statement from the attending
Board-Certified Cardiothoracic Surgeon or
Board-Certified Cardiologist, supported by
medical records.
See Settlement Agreement

IV.B.2.c. {5) (c).

§

The Estate

essentially argues that it should not be required to comply with
this portion of the Settlement Agreement.

We, however, must

apply the Settlement Agreement as written.

Accordingly, the

Estate is not entitled to receive benefits under this section of
the Settlement Agreement. 10
We also find that the Estate has not established that
it is eligible to receive Matrix Benefits based on damage to
decedent's mitral valve.

The Settlement Agreement states that a

representative claimant is eligible for Matrix Benefits only if
the Diet Drug Recipient "ha[s] been diagnosed by a Qualified

10. Given our disposition, we need not determine whether
Mr. Bonzo actually died as a result of a condition caused by VHD.
-10-

Physician as FDA Positive 11 or as having Mild Mitral
Regurgitation by an Echocardiogram performed between the
commencement of Diet Drug use and the end of the Screening
Period."

Settlement Agreement§ IV.B.l.b.

Thus, the Estate must

establish that decedent had at least mild mitral regurgitation to
be eligible to seek Matrix Benefits for damage to his or her
mitral valve . 12
As an initial matter, the Estate's argument that the
Trust improperly relied on the echocardiogram report rather than
the findings set forth in the affidavit of Dr. Levene is
misplaced.

Although the Estate correctly notes that the

Settlement Agreement permits a claimant or representative
claimant to supply an affidavit from the person who last had
custody of an echocardiogram tape or disk if the echocardiogram
tape or disk is no longer in existence, nothing in the Settlement
Agreement or Audit Rules suggests that such affidavit
conclusively establishes the Green Form representation at issue

11. The Settlement Agreement defines FDA Positive, in pertinent
part, as "mild or greater regurgitation of the aortic valve
and/or moderate or greater regurgitation of the mitral valve."
Settlement Agreement § I.22.
12. The Estate's claim for Level V benefits is based on Section
IV.B.2.c. (5} (d), which requires a decedent to "otherwise
qualif[y] for payment at Matrix Level II, III or IV" and to have
"suffer[ed] from ventricular fibrillation or sustained
ventricular tachycardia which results in hemodynamic compromise."
The Estate's claim for Level V benefits is based solely on damage
to decedent's mitral valve. Thus, to recover Matrix Benefits
under this section, the Estate must establish that the
December 19, 1997 echocardiogram demonstrated moderate mitral
regurgitation.
-11-

or that an auditing cardiologist is precluded from considering
other information.
Pursuant to Section VI.C.4.b. of the Settlement
Agreement, in the case of a missing echocardiogram tape or disk,
the Trust has the right to consider other documents submitted in
support of a claim.

Specifically, Section VI.C.4.b. provides:

If the Class Member seeking a Matrix payment
is unable to obtain the documentation
described above through the exercise of
reasonable efforts, the Trustees and/or
Claims Administrator(s) shall have the right
to consider other supporting documentation
including but not limited to declarations of
other Qualified Physician(s) under penalty of
perjury setting forth opinion(s) to a
reasonable degree of medical certainty to
support the claim that the Class Member's
condition entitles him or her to a Matrix
payment, subject to review by the Court as
set forth in Section VIII.D. If this
evidence establishes the Class Member's
condition to the satisfaction of the Trustees
and/or Claims Administrator(s), the Class
Member shall be entitled to receive the
appropriate Matrix Compensation Benefits.
The Trust reviewed the documents submitted by the
Estate in support of its claim and determined that there was no
reasonable basis for the attesting physician's conclusion that
the December 19, 1997 echocardiogram demonstrated moderate mitral
regurgitation. 13

We agree.

Neither the Estate nor the attesting

13. We reject claimant's argument that an auditing cardiologist
is not permitted, in the case of a missing echocardiogram, to
review other supporting documentation, including an
echocardiogram report and other medical records submitted by a
claimant, to determine whether a reasonable medical basis exists
for the attesting physician's representations. In any event, we
find that the Trust's decision to deny the Estate's claim was
(continued ... )
-12-

physician, Dr. Levene, identified any medical record or
supporting documentation contemporaneous with the echocardiogram
that would support a finding of either mild or moderate mitral
regurgitation.

Instead, the Estate relies on Dr. Levene's

statement that he reviewed the actual echocardiogram and
determined it demonstrated moderate mitral regurgitation and that
the term "transient," used in the echocardiogram report by the
reviewing cardiologist, Dr. Fellows, was "vague."

The

echocardiogram report, however, stated, "[T]ransient mitral
regurgitation and transient to mild aortic insufficiency."

It is

clear, given that Dr. Fellows described decedent's mitral
regurgitation as "transient" and his aortic regurgitation as
"transient to mild," that the word "transient" as used by Dr.
Fellows indicates something less than mild.

Under these

circumstances, we find that the Estate has failed to meet its
burden of proving that there is a reasonable medical basis for a
representation that decedent had at least mild mitral
regurgitation based on the December 19, 1997 echocardiogram.
Moreover, we reject the Estate's argument that it may
establish the requisite level of mitral regurgitation by
reference to decedent's Autopsy Report.

As we previously held in

PTO No. 7091 at 4 (Apr. 5, 2007), the eligibility language

13.
( ... continued)
appropriate independent of the auditing cardiologist's finding.
For this reason as well, we need not reach claimant's arguments
with respect to whether the auditing cardiologist complied with
the Audit Rules.
-13-

contained in Section IV.B.1. specifically requires that
eligibility be established "by an Echocardiogram."

The results

of an autopsy performed more than 18 months after the
echocardiogram submitted in support of a claim cannot provide a
reasonable medical basis for representations based on the
echocardiogram.
For the foregoing reasons, we conclude that the Estate
has not met its burden in proving that there is a reasonable
medical basis for its Level V Matrix claim.

Therefore, we will

affirm the Trust's denial of the Estate's claim for Matrix
Benefits and the related derivative claim submitted by
Mr. Bonzo's spouse.

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