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

Filing 4756

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9059 RE: CLAIMANT DIANNE T. COFER. SIGNED BY HONORABLE HARVEY BARTLE, III ON 5/8/2013; 5/9/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109970 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

__________________________________ )
)

v.

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)
)
)
)

AMERICAN HOME PRODUCTS
CORPORATION

)
)

THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.

CIVIL ACTION NO. 99-20593

)

2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

Bartle, J.

qD59

May

8',

2013

Dianne T. Cofer ("Ms. Cofer" or "claimant"), a class
member under the Diet Drug Nationwide Class Action Settlement
Agreement ("Settlement Agreement") with Wyeth,
from the AHP Settlement Trust ("Trust") . 2

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") . 3

1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
2.
Thomas N. Cofer, Ms. Cofer'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 ... )

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 April, 2005, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Andrew S.
Fireman, M.D.

Dr. Fireman is no stranger to this litigation.

According to the Trust, he has attested to at least 92 Green
Forms on behalf of claimants seeking Matrix Benefits.

Based on

an echocardiogram dated May 2, 2001, Dr. Fireman attested in
Part II of Ms. Cofer's Green Form that she suffered from severe
mitral regurgitation and had surgery to repair or replace the
aortic and/or mitral valve(s) after use of Pondimin® and/or

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.
-2-

Redux™. 4

Based on such findings, claimant would be entitled to

Matrix A-1, Level III benefits in the amount of $748,344. 5
Dr. Fireman also attested in claimant's Green Form that
Ms. Cofer did not suffer from mitral valve prolapse.

Mitral

valve prolapse is defined in the Settlement Agreement as:
[A] condition where (a) the echocardiogram
video tape or disk includes the parasternal
long axis view and (b) that echocardiographic
view shows displacement of one or both mitral
leaflets >2mm above the atrial-ventricular
border during systole, and >Smm leaflet
thickening during diastole, as determined by
a Board-Certified Cardiologist.
Settlement Agreement

I.39.

§

Under the Settlement Agreement, the

presence of mitral valve prolapse requires the payment of reduced
Matrix Benefits.

Id.

§

IV.B.2.d. (2) (c)ii)b).

As the Trust does

not contest Ms. Cofer's entitlement to Level III benefits, the
only issue before us is whether claimant is entitled to payment
on Matrix A-1 or B-1.
In January, 2006, the Trust forwarded the claim for
review by Waleed N. Irani, M.D., one of its auditing
cardiologists. 6

In audit, Dr. Irani concluded that there was no

4. Dr. Fireman also attested that claimant suffered from a
reduced ejection fraction in the range of SO% to 60% and New York
Heart Association Functional Class II 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.

Pursuant to Pretrial Order ("PTO") No. 3882 (Aug. 26, 2004),
(continued ... )
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reasonable medical basis for the attesting physician's finding
that claimant did not have mitral valve prolapse.

In support of

this conclusion, Dr. Irani stated that the "[echocardiogram]
dated 5/2/01 [was] of borderline quality with no obvious [mitral
valve] prolapse - cardiac [catherization] dated 5/16/01 with
evidence of bileaflet prolapse."
Based on Dr. Irani's finding that claimant had mitral
valve prolapse, the Trust issued a post-audit determination that
Ms. Cofer 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 the auditing cardiologist's
determination of mitral valve prolapse was improper because it
was based on the report of the cardiac catheterization rather
than a review of an echocardiogram as required by the Settlement
Agreement.

In addition, Ms. Cofer submitted a Declaration from

Manoj R. Muttreja, M.D., who opined, in relevant part, as
follows:

6.
( ... continued)
all Level III, Level IV, and Level V Matrix claims were subject
to the Parallel Processing Procedures ("PPP"). As Wyeth did not
agree that Ms. Cofer had a Matrix A-1, Level III claim, the Trust
audited Ms. Cofer's claim.
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 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. Cofer's claim.
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2.

I reviewed a copy of the
above-referenced Claimant's left
ventriculography videotape dated
May 16, 2001, a copy of the
transthoracic echocardiogram (TTE)
videotape dated May 2, 2001, and I
reviewed a copy of the Claimant's
transesophageal echocardiogram (TEE)
videotape dated May 16, 2001.

3.

I reviewed these two echocardiogram and
one left ventriculography videotapes, in
detail, for the purpose of finding any
evidence of mitral valve prolapse (MVP) .

4.

On the basis of my review of these two
echocardiogram and one left
ventriculography videotapes, I found no
evidence of MVP.

5.

In addition to my review of these three
videotapes, I reviewed the cardiac
catheterization report dated May 16,
2001, wherein the doctor stated that he
found "Prolapse of the anterior and
posterior mitral valve leaflets."

6.

In my review of the TTE videotape dated
May 2, 2001, I had clear parasternal
long-axis views of both the anterior and
posterior mitral valve leaflets as well
as other views of these leaflets. MVP
was clearly not present. The cardiac
catheterization report, or even the left
ventriculography itself, cannot be used
to contradict the findings that I
personally observed on the TTE.

Although not required to do so, the Trust forwarded the
claim for a second review by the auditing cardiologist.
Dr. Irani submitted a declaration in which he again concluded
that there was no reasonable medical basis for the attesting
physician's finding that Ms. Cofer did not have mitral valve
prolapse.

Dr. Irani stated, in relevant part:

-5-

7.

In light of Claimant's Contest, I was
contacted by the Trust and asked to
review Claimant's Contest Materials, as
well as a copy of Claimant's
transthoracic echocardiogram (TTE)
videotape dated May 2, 2001, Claimant's
transesophageal echocardiogram (TEE)
videotape dated May 16, 2001 and
Claimant's cardiac catheterization tape
dated May 16, 2001.

8.

In accordance with the Trust's request,
I carefully reviewed the entirety of all
3 tapes (TTE, TEE and cardiac
catheterization), as well as Claimant's
other Contest Materials.

9.

Upon careful and thorough review of the
May 2, 2001 TTE, I found that there is
posterior leaflet prolapse seen with an
anteroseptally directed jet of mitral
regurgitation. The image quality
precludes exact measurement of the
distance that the posterior leaflet
prolapses, however, visually it appears
to be 5 mm.

10.

Upon careful and thorough review of the
May 16, 2001 TEE, I found ... clear
mitral valve prolapse.

11.

Upon careful and thorough review of the
May 16, 2001 cardiac catheterization I
found that mitral valve prolapse is
present.

12.

I also re-reviewed and considered the
cardiac catheterization report
accompanying the May 16, 2001 cardiac
catheterization tape, wherein the doctor
confirmed that there was "Prolapse of
the anterior and posterior mitral valve
leaflets."

13.

Based on my review of the 3 tapes (TTE,
TEE and cardiac catheterization) , the
cardiac catheterization report and
Claimant's other Contest Materials, I
affirm my findings at audit, that there
is no reasonable medical basis for a
finding that the Claimant does not have
-6-

mitral valve prolapse as defined in the
Settlement Agreement.
The Trust then issued a final post-audit determination,
again determining that Ms. Cofer 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. Cofer's claim should be paid.

On November 20, 2006, we

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

See PTO No. 6696

(Nov. 20, 2006).
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 5, 2007, and

claimant submitted a sur-reply on February 27, 2007.

Under the

Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor 8 to review claims after the Trust and
claimant have had the opportunity to develop the Show Cause

8. 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 there
are conflicting expert opinions, a court may seek the assistance
of the Technical Advisor to reconcile such opinions. The use of
a Technical Advisor to "reconcil[e] the testimony of at least two
outstanding experts who take opposite positions" is proper.
Id.
-7-

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
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 she did not have mitral valve prolapse as defined in the
Settlement Agreement.

See id. Rule 24.

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.

See id. Rule 38(a).

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. Cofer reasserts the
arguments made in contest.

Claimant also argues that she has

established a reasonable medical basis for the attesting
physician's finding that she did not have mitral valve prolapse
as defined in the Settlement Agreement because "the Trust has
offered no evidence in support of its claim that it met the
definition of [mitral valve prolapse] that is found in the
-8-

Settlement Agreement." 9

She also contends Dr. Irani did not use

the criteria set forth in the Settlement Agreement.
Specifically, claimant asserts the auditing cardiologist failed
to state whether he determined the presence of mitral valve
prolapse in the parasternal long axis view and that the mitral
valve prolapse found to be present exceeded 2 mm in systole and
5 mm in diastole, as required by the Settlement Agreement.
Further, claimant contends that Dr. Irani is not qualified to
diagnose mitral valve prolapse because his curriculum vitae does
not evidence that he is an invasive cardiologist or that he is
Board-Certified.
In response, the Trust argues that the auditing
cardiologist is Board-Certified and complied with the terms of
the Settlement Agreement because he found mitral valve prolapse
of 5 mm on claimant's May 2, 2001 echocardiogram and observed
mitral valve prolapse on claimant's May 16, 2001 echocardiogram
and cardiac catheterization.

The Trust also argues that

claimant's medical records support the finding of mitral valve
prolapse as her June 11, 2001 operative report notes "a long
history of mitral valve prolapse."

Finally, the Trust argues

that Dr. Muttreja's Declaration does not provide a reasonable
medical basis for Dr. Fireman's Green Form representation because

9.
Claimant also asserts that the issue of reasonable medical
basis should be controlled by Gallagher v. Latrobe Brewing Co.,
31 F.R.D. 36 (W.D. Pa. 1962). We repeatedly have rejected the
Gallagher decision as controlling or persuasive. See, e.g., PTO
No. 6275 (May 19, 2006).
-9-

he does not deny the existence of mitral valve prolapse on
claimant's cardiac catheterization.
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 Ms. Coffer did not have mitral valve prolapse.
Specifically, Dr. Vigilante stated, in relevant part, that:
I reviewed the Claimant's echocardiogram of
attestation dated May 2, 2001.

I digitized the cardiac cycles in the
parasternal long-axis view and made
measurements with electronic calipers. There
was displacement of the posterior leaflet
4 mm above the atrial-ventricular border
during systole. The posterior mitral leaflet
measured 7 mm in thickness during diastole.
Additionally, prolapse of the posterior
mitral leaflet was noted in the apical two
chamber view.
Findings on this
echocardiogram correlate with the findings
noted at the time of surgery by Dr. Ewing.
At that time, he stated, "The valve did
indeed show changes of myxoid degeneration.
There was some prolapse of the anterior
leaflet, but this did not appear to be
severe. The primary area of leak appeared to
be at the posterior or non-aortic commissure
where there was some prolapse and the
leaflets did not coapt."

I reviewed the Claimant's transesophageal
echocardiogram of May 16, 2001 .... There was
clear evidence of prolapse of the posterior
mitral left leaflet at the 139 degree to 180
degree views.
This prolapse primarily
occurred in the P1 segment of the posterior
mitral leaflet ....

-10-

I reviewed the Claimant's cardiac
catheterization of May 16, 2001 .... After
the first two premature ventricular beats, it
was clear that significant prolapse occurred
with "billowing' of the mitral valve into the
left atrium during systole consistent with
significant mitral valve prolapse ....
[T]here is no reasonable medical basis
for the Attesting Physician's answer to Green
Form Question D.7. That is, I was able to
determine that the echocardiogram of
attestation demonstrated mitral valve
prolapse as defined in the Green Form. This
finding was also supported by the findings on
the transesophageal echocardiogram, cardiac
catheterization and by the findings at the
time of the cardiac surgery. An
echocardiographer could not reasonably
conclude that mitral valve prolapse was not
present on this study even taking into
account inter-reader variability.
After reviewing the entire Show Cause Record, we find
the claimant's arguments are without merit.

The Settlement

Agreement requires that a claim for damage to the mitral valve be
reduced to Matrix B-1 if he or she has mitral valve prolapse.
Settlement Agreement

§

IV.B.2.d. (2) (c)ii)b).

As noted above,

mitral valve prolapse is defined as:
[A] condition where (a) the echocardiogram
video tape or disk includes the parasternal
long axis view and (b) that echocardiographic
view shows displacement of one or both mitral
leaflets >2mm above the atrial-ventricular
border during systole, and >Smm leaflet
thickening during diastole, as determined by
a Board-Certified Cardiologist.
Id.

§

I.

39.
Claimant has not satisfied her burden of establishing

that there was a reasonable medical basis for Dr. Fireman's
finding that she did not have mitral valve prolapse.
-11-

Although

Ms. Cofer contests the findings of the auditing cardiologist
because he relied on a cardiac catheterization rather than an
echocardiogram, Dr. Irani subsequently re-reviewed Ms. Cofer's
submissions and determined that claimant's echocardiograms of
May 2, 2001 and May 16, 2001 and her cardiac catheterization of
May 16, 2001 all demonstrated mitral valve prolapse.

Thus, we

reject claimant's argument that Dr. Irani relied solely on
claimant's cardiac catheterization as the basis for his finding.
We also disagree with Ms. Cofer that the Declaration of
Dr. Muttreja provides a reasonable medical basis for
Dr. Fireman's representation that claimant did not have mitral
valve prolapse.

Although Dr. Muttreja states, in conclusory

fashion without any measurements or specific detail regarding
claimant's echocardiograms or catheterization, that Ms. Cofer did
not have mitral valve prolapse, the Technical Advisor,
Dr. Vigilante, reviewed claimant's echocardiograms and cardiac
catheterization and concluded that they demonstrated mitral valve
prolapse as defined by the Settlement Agreement. 10

Specifically,

with respect to Ms. Cofer's May 2, 2001 echocardiogram,
Dr. Vigilante observed that, in the parasternal long-axis view,
"there was displacement of the posterior leaflet 4 mm above the
atrial-ventricular border during systole" and that the "posterior
mitral leaflet measured 7 mm in thickness during diastole."

10. Despite the opportunity to do so, claimant did not submit a
response to the Technical Advisor Report. See Audit Rule 34.
-12-

These measurements satisfy the definition of mitral valve
prolapse set forth in the Settlement Agreement.

As claimant does

not identify any specific errors by Dr. Vigilante, she cannot
meet her burden of proof.
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 mitral valve
prolapse as defined in the Settlement Agreement.

Therefore, we

will affirm the Trust's denial of Ms. Cofer's claim for Matrix A
benefits and the related derivative claim submitted by her
spouse.

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