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

Filing 4671

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9012 RE: CLAIMANT GLENDA S. MACY. SIGNED BY HONORABLE HARVEY BARTLE, III ON 2/28/2013; 2/28/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109887 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.

)
)
)

v.
AMERICAN HOME PRODUCTS
CORPORATION

)
)

CIVIL ACTION NO. 99-20593
2:16 MD 1203

)

MEMORANDUM. IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

Bartle, J.

February

012
li",

2 0 13

Glenda S. Macy ("Ms. Macy" 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 hgreement §§ 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 at. testing 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 August, 2003, claimant submitted Part II of a Green
Form to the Trust signed by her attesting physician, Antoine M.
Adem, M.D., in which she sought Matrix A-1, Level II benefits. 3
Based on an •::!chocardiogram dated June 18, 2002, Dr. Adem attested
that claimant had severe mitral regurgitation, pulmonary
hypertension secondary to moderate or greater mitral
regurgitation, an abnormal left atrial dimension, and a reduced

2.
( ... continued)
serious VHD who took the drugs for 61 says 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 re9ristered as having only mild mitral regurgitation by
the close of the Screening Period or who took the drugs for 60
days or les::1. or who has factors that would make it difficult for
them to pro,re that their VHD was caused solely by the use of
these Diet Drugs.
3. Ms. Mac·y also submitted a second Part II of a Green Form
signed by Dr. Adem in which she sought Matrix A-1, Level III
benefits. This Part II is not relevant to disposition of this
claim.
-2-

ejection fraction in the range of SO% to 60%. 4

Dr. Adem also

attested that claimant did not have chordae tendinae rupture.

5

Based on these findings, claimant would be entitled to Matrix
A-1, Level II 6 benefits in the amount of $340,223. 7
In February, 2004, the Trust forwarded the claim for
review by Ernest C. Madu, M.D., F.A.C.C., F.E.S.C., one of its
auditing cardiologists.

In audit, Dr. Madu concluded that there

was a reasonable medical basis for Dr. Adem's findings that
claimant had severe mitral regurgitation, an abnormal left atrial
dimension, a:nd pulmonary hypertension secondary to moderate or

4.
Dr. Adem also attested that claimant had surgery to repair or
replace her mitral valve after use of Pondimin® and/or Redux™ and
New York Heart Association Functional Class III symptoms.
These
conditions are not at issue in this claim.
5. The Settlement Agreement provides that a claim will be
reduced to the B-1 Matrix if a claimant pursuing a claim for
Matrix Benefits for damage to the mitral valve has chordae
tendinae ru:J;::,ture.
See Settlement § IV.B.2.d. (2) (c) (ii) (c).
6. Under tl:1e Settlement Agreement, a claimant is entitled to
Level II benefits for damage to the mitral valve if he or she is
diagnosed with moderate or severe mitral regurgitation and one of
five complicating factors delineated in the Settlement Agreement.
See Settlement Agreement § IV.B.2.c. (2) (b).
Pulmonary
hypertension secondary to moderate or greater mitral
regurgitation, an abnormal left atrial dimension, and a reduced
ejection fraction in the range of 50% to 60% are each one of the
complicatinq factors needed to qualify for a Level II claim.
7.
Ms. Macy previously was paid Matrix B-1, Level III benefits
in the amount of $136,664. According to the Trust, if entitled
to Matrix A-1, Level II benefits, claimant would be entitled to
Matrix Benefits in the amount of $476,887. The amount at issue,
therefore, is the difference between the Matrix B-1, Level III
benefits already paid and the amount of Matrix A-1, Level II
benefits.
-3-

greater mitral regurgitation.

Dr. Madu also determined that

Ms. Macy did not suffer from chordae tendinae rupture.
By letter dated March 30, 2004, the Trust advised
Ms. Macy that her claim was potentially payable on Matrix A and
requested additional medical records pursuant to Court Approved
Procedure ("CAP") No. 4, as adopted in Pretrial Order ("PTO")
No. 2805 (Mar. 26, 2003).

Following a review of claimant's

additional medical records, Dr. Madu issued an amended Report of
Auditing Cardiologist Opinions Concerning Green Form Questions at
Issue.

In particular, Dr. Madu determined that there was no

reasonable medical basis for Dr. Adem's findings that claimant
did not have chordae tendinae rupture.

Dr. Madu explained,

"The

operative report submitted by claimant clearly indicates the
presence of •ruptured chordae tendinae to the anterior valve
leaflet.'"
Ba:sed on Dr. Madu • s amended finding that claimant had
chordae tendinae rupture, the Trust issued a post-audit
determination that Ms. Macy was entitled only to Matrix B-1,
Level II ben1:!fits. 8

Pursuant to the Rules for the Audit of

Matrix Compen.sation Claims ("Audit Rules"), claimant contested

8. As the Trust does not contest Ms. Macy•s entitlement to Level
II benefits, the only issue before us is whether claimant is
entitled to payment on Matrix A-1 or Matrix B-1.
If Ms. Macy•s
claim for Level II benefits is payable only on Matrix B-1,
Ms. Macy will not receive any additional payment because the
amount to which she would be entitled for her Matrix B-1, Level
II claim is less than the amount she already received for her
Matrix B-1, Level III claim.
See Settlement Agreement § IV.C.3.
-4-

this adverse determination. 9

In contest, claimant argued that

she should prevail because she did not have chordae tendinae
rupture at the time she first qualified for Level II benefits.
In support, claimant relies on echocardiograms dated
August 28, 1998, June 18, 2002 (the echocardiogram of
attestation),, and October 7, 2002.

She also submitted affidavits

of Randall G . Johnson, M.D., and Gary S. Benton, M.D.

In his

affidavit, Dr. Johnson stated that he received claimant's
October 7, 2002 transesophageal echocardiogram and "saw no
evidence of ruptured mitral valve chordae tendinae."

According

to claimant, a transeophageal echocardiogram provides a better
view of the mitral valve than a transthoracic echocardiogram.

In

the second affidavit, Dr. Benton, the surgeon who performed
Ms. Macy's mitral valve replacement surgery, stated that he
noticed claimant had ruptured chordae tendinae but opined,
without any explanation, that the rupture occurred subsequent to
Ms. Macy's June 19, 2002 coronary artery bypass surgery.
The Trust then issued a final post-audit determination,
again denying Ms. Macy's claim for Matrix A-1, Level II Benefits.
Claimant .disputed this final determination and requested that the
claim proceed to the show cause process established in 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 (Mc>LY 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. Macy's claim.
-5-

Settlement A9reement.

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. Macy•s claim
should be paid.

On May 20, 2005, we issued an Order to show

cause and reJ:erred the matter to the Special Master for further
proceedings.

See PTO No. 5239 (May 20, 2005).

Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
documentatio:n.
Master.

Claimant then served a response upon the Special

The Trust submitted a reply on November 10, 2005, and

claimant submitted a sur-reply on December 2, 2005.

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. Audit Rule 30.

The Special Master assigned a

Technical Advisor, Sandra V. Abramson, 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.

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
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 .:. .
-6-

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. Macy did not have chordae tendinae rupture.
Rule 24.

See id. at

Ult:imately, if we determine that there was 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.
at Rule 38(a).

See id.

If, on the other hand, we determine that there

was a reasona.ble medical basis for the answer, we must enter an
Order directing the Trust to pay the claim in accordance with the
Settlement A9reement.

See id. at Rule 38(b).

In support of her claim, claimant argues that "[t]he
issue presented is whether a claim that meets every criterion for
payment on the A Matrix is invalidated by the subsequent
development of a reduction factor."

Ms. Macy asserts that her

chordae tendinae rupture did not develop until after the date of
the echocarCI.iogram that forms the basis of her claim for Matrix
A-1, Level II Benefits - June 18, 2002.

Ms. Macy contends that

"it defeats the purpose of the reduction factors to apply them
retroactively insofar as the regurgitation previously came to
existence without the contribution of a reduction factor." 11

11. Claimant concedes that the condition of chordae tendinae
rupture was present by the time of her mitral valve replacement
surgery.
-7-

In response, the Trust argues that Dr. Madu properly
based his finding of chordae tendinae rupture on his review of
claimant's operative report and the echocardiogram of
attestation.

The Trust also contends that, under the

~ettlement

Agreement, the presence of chordae tendinae rupture reduces a
mitral valve claim to the B-1 Matrix, regardless of whether the
chordae tendinae rupture is present on the echocardiogram of
attestation.
The Technical Advisor, Dr. Abramson, reviewed
claimant's June 18, 2002 echocardiogram and concluded that there
was no reasonable medical basis for Dr. Adem's finding that
claimant did not have chordae tendinae rupture.

In particular,

Dr. Abramson explained:
Based on my review of the Special Master
Record, including the two Green Forms, seven
echo reports, affidavits from two other
physicians, the report of the Auditing
Cardiologist, the operative report, the
transthoracic echocardiogram from 6/18/02,
ar.1.d the transeophageal echocardiogram from
10/7/02, there are ruptured chordae tendinae
on the echocardiogram of 6/18/02 and there is
no reasonable medical basis for the physician
completing the diet-drug recipient's claim
form to state that Glenda Macy did not have a
chordae tendinae rupture.

I reviewed the TTE from 6/18/02 and the TEE
from 10/07/02....
In two views, short axis
of the LV (-1:23:30-1:23:20) and a zoomed in
apical-4-chamber (-1:12:10-1:11:50), there
are hypermobile linear echodensities in the
area of the subvalvular mitral apparatus
which generally represent ruptured chordae
tendinae.
It is unlikely that these
h;roermobile structures represent redundant
-8-

chordae since the surgeon clearly saw the
ruptured chordae when he inspected the mitral
valve during the 3/06/03 surgery.
The TEE
also demonstrates oscillating structures
attached to the anterior mitral leaflet
(00:00:21-00:00:26) which also represent
ruptured chordae.
Signs of hypertrophic
ohstructive cardiomyopathy including LVH with
basal septal thickening, LVOT gradient and
moderate [mitral regurgitation] are also
present on the TEE.
To summarize this Claimant's complicated
cardiac issues, she has hypertrophic
obstructive cardiomyopathy with at least
moderate [mitral regurgitation] which was
noted on her TTE from 7/18/98 and mentioned
in subsequent echocardiograms (except the TEE
from 10/07/02-which did not mention LVH, but
it was present upon my review) including the
study from 2/26/03.
This is a disease
process (also known as IHSS) which usually
causes mitral regurgitation.
In the 6/18/02
echo, she was reported as having moderate to
severe [mitral regurgitation] , which is the
same [mitral regurgitation] severity as the
2/26/03 echo.
If the ruptured chordae
occurred during the time interval between the
t\l;ro echocardiograms, the severity of the
[mitral regurgitation] should have worsened,
wrlich it did not. This disease process
(IHSS) is also associated with ruptured
chordae tendinae, "Chordal rupture may ... be
secondary to rheumatic heart disease,
bacterial endocarditis, mitral valve
prolapse, connective tissue disorders,
myocardial infarction, idiopathic
hypertrophic subaortic stenosis (IHSS) and
trauma" (Weyman, 2nd ed, p. 458).
The
hypermobile structures seen in the LV in both
the 6/18/02 and 10/07/02 echocardiograms
represent ruptured chordae tendinae as
described in the operative report from
3/06/03. These were not noticed during the
surgery on 6/19/02, because you do not open
up the ventricle during coronary artery
bypass surgery as you do for mitral valve
surgery.
In summary, (1) chordae tendinae rupture can
be determined from the Claimant's
-9-

echocardiogram of 6/18/02. (2) The Claimant
did have a chordae tendinae rupture when her
echocardiogram was taken on 6/18/02.
(3) There is no reasonable medical basis for
the Attesting Physician to state that the
chordae tendinae rupture is not evident on
the 6/18/02 echocardiogram.
After reviewing the entire show cause record, we find
claimant's
submitted

a:~::-guments

th•:~

to be without merit.

Although claimant

affidavits of Dr. Johnson and Dr. Benton, neither

physician stated that he had reviewed claimant's June 18, 2002
echocardiogra.m and determined that it did not demonstrate chordae
tendinae rupture.

Dr. Abramson, on the other hand, reviewed

claimant's June 18, 2002 echocardiogram and specifically
determined tb.at there was evidence of chordae tendinae rupture.
Dr. Abramson also determined that Dr. Johnson's and Dr. Benton's
opinions that Ms. Macy's chordae tendinae rupture occurred after
June 18, 2002 were unsupported.

As explained by Dr. Abramson, if

Ms. Macy's chordae tendinae ruptured between her June 18, 2002
and February 26, 2003 echocardiograms the severity of her mitral
regurgitation would have worsened, but it did not . 12
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 chordae tendinae
rupture.

Therefore, we will affirm the Trust's denial of

Ms. Macy's claim for Matrix A-1, Level II benefits.

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