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

Filing 5034

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9218 RE: CLAIMANT MICHELE E. LEE. SIGNED BY HONORABLE HARVEY BARTLE, III ON 3/26/2014; 3/26/2014 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110247 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.

9~18

March l.6, 2014

Bartle, J.

Michele E. Lee ("Ms. Lee" 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, Stephen
Raskin, M.D.

Based on an echocardiogram dated March 25, 2010, 3

Dr. Raskin attested in Part II of claimant's Green Form that
Ms. Lee suffered from moderate mitral regurgitation and had
surgery to repair or replace the aortic and/or mitral valve(s)

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. Because claimant's March 25, 2010 echocardiogram was
performed after the end of the Screening Period, claimant relied
on an echocardiogram dated November 23, 1998 to establish her
eligibility to receive Matrix Benefits.
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following the use of Pondimin® and/or Redux™. 4

Based on such

findings, claimant would be entitled to Matrix A-1, Level III
benefits. 5
Dr. Raskin also attested in claimant's Green Form that
Ms. Lee suffered from mitral annular calcification.

Under the

Settlement Agreement, the presence of mitral annular
calcification requires the payment of reduced Matrix Benefits.
See Settlement Agreement§ IV.B.2.d. (2) (c)ii)d).

As the Trust

does not contest Ms. Lee's entitlement to Level III benefits, the
only issue before us is whether claimant is entitled to payment
on Matrix A-1 or Matrix B-1.
In April, 2011, the Trust forwarded the claim for
review by Waleed Irani, M.D., F.A.C.C., one of its auditing
cardiologists. 6

In audit, Dr. Irani concluded that there was a

reasonable medical basis for Dr. Raskin's finding that Ms. Lee
had mitral annular calcification.

4. Dr. Raskin also attested that claimant suffered from
pulmonary hypertension secondary to moderate or greater 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™. 11 See Settlement Agreement§ IV.B.2.c. (3) (a).
6. Ms. Lee's claim originally was audited in December, 2010, but
was subjected to re-audit pursuant to Court Approved Procedure
No. 11.
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Based on the auditing cardiologist's finding, the Trust
issued a post-audit determination that Ms. Lee 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 audit and her Green Form "are all mistaken" as to
the presence of mitral annular calcification because the "best
evidence" is the surgeon's operative report, which does not
mention mitral annular calcification.

Claimant also contended

that the fact that the initial auditing cardiologist did not find
mitral annular calcification on her November 23, 1998
echocardiogram provides additional support for the assertion that
she did not have mitral annular calcification.
In addition, claimant submitted a letter from
Dr. Raskin in which he stated, in relevant part, that the
March 25, 2010 "echocardiogram suggests that the slightly more
prominent mitral annular echoreflectance without echo shadowing
is most likely explained by the acoustic proportion of fibrosis
and the exaggerating effect of tissue harmonic imaging and not to
annular calcification."

(Emphasis in original.)

Accordingly,

Dr. Raskin stated, "The previously reported finding of [mitral

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. Lee's claim.
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annular calcification] as noted in the 3/25/10 pre-operative
Green Form is incorrect and should be amended.

118

Claimant also submitted a declaration of Kamal
Khabbaz, M.D., the surgeon who performed her mitral valve
surgery.

Dr. Khabbaz stated, in penitent part:
My operative report 4/5/10 for Ms. Lee
carefully described the procedure conducted
on Ms. Lee, a mitral valve replacement with a
27-mm St. Jude Medical Epic tissue valve.
Whenever I perform a mitral valve
replacement, I carefully study and always
describe in my operative report the presence
of any mitral annular calcification because
its presence is very significant to such
surgery. The presence of mitral annular
calcification requires the area to be
debrided to successfully accept a prosthetic
valve.
In the case of Michele Lee, my operative
report reveals no mitral annular
calcification and, as a result, she did not
have mitral annular calcification.
If she
had had mitral annular calcification, I would
have had to debride her valve prior to
replacing it and no such debridement is
reflected in the operative report and no such
debridement occurred. Again, that is because
she did not have mitral annular
calcification.
Although not required to do so, the Trust forwarded the

claim to Dr. Irani for a second review.

Dr. Irani submitted a

declaration in which he again concluded that, consistent with
Dr. Raskin's initial Green Form representation, claimant had
mitral annular calcification and Dr. Raskin's later assertion

8.
In addition, claimant included "a new superseding Green Form
Submission," signed by Dr. Raskin, wherein he stated that Ms. Lee
did not suffer from mitral annular calcification.
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that claimant did not have mitral annular calcification lacked a
reasonable medical basis.

Specifically, Dr. Irani stated, in

pertinent part, that:
10.

Based on my review, I find that there is
no reasonable medical basis for
Dr. Raskin's representation, at Question
D.9 of the Green Form signed on
June 1, 2011, that Claimant did not have
mitral annular calcification. At
Contest, I reviewed the March 25, 2010
echocardiogram several times. Mitral
annular calcification ("MAC") is
certainly present and it is unreasonable
to say it is not. MAC is present in the
parasternal long axis view, apical 4
chamber and apical 2 chamber.
This is
not merely increased echoreflectance.
There is additionally calcification
present in the aortic annulus and
ascending aorta. The presence of MAC in
multiple views lends support to its
presence.

11.

Dr. Khabbaz did not note mitral annular
calcification at the time of Claimant's
April 5, 2010 surgery, as he states in
his Declaration submitted at Contest.
However, MAC was not severe on the
March 25, 2010 [echocardiogram].
Such
mild mitral annular calcification would
likely not be noted by a surgeon upon
visual inspection, and would not affect
the surgeon's approach to the surgery.

The Trust then issued a final post-audit determination,
again determining that Ms. Lee 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

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show cause why Ms. Lee's claim should be paid.

On November 29,

2011, we issued an Order to show cause and referred the matter to
the Special Master for further proceedings.

See PTO No. 8711

(Nov. 29, 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 February 24, 2012, and

claimant submitted a sur-reply on June 27, 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.
Audit Rule 30.

See

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 she did not have mitral

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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annular calcification.

See id. Rule 24.

Ultimately, if we

determine that there is no reasonable medical basis for the
finding, 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 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. Lee reasserts the
arguments made in contest.

Specifically, claimant argues that

the statement of Dr. Khabbaz that he did not see mitral annular
calcification during claimant's mitral valve surgery "should
trump any alleged interpretation of grainy [echocardiogram]
images" because claimants are permitted to rely on surgical
examinations to support a claim for Matrix Benefits and such
direct medical examinations are the "best evidence" and the "gold
standard" for determining whether mitral annular calcification is
present.

In addition, claimant submitted another letter from

Dr. Raskin dated September 6, 2011, which stated, in pertinent
part:
Michele Lee's 4/02/10 cardiac angiogram
revealed no occlusive or severe coronary
atherosclerosis. Dr. Khabbaz•s operative
note and his subsequent written report
confirmed by both visual and palpable
examination the absence of mitral annular
calcification. The failure to document
[mitral annular calcification] by intraoperative [transesophageal echocardiogram] ,
and my critical review of Michele Lee's
3/25/2010 echocardiogram supports the
-8-

observation that [mitral annular
calcification] is not present.
According to claimant, Dr. Raskin's letter explains "why any
[echocardiogram] suggestions of the possibility of [mitral
annular calcification] are wrong and also contradicted by the
absence of significant coronary artery disease."
In response, the Trust argues that claimant's
submissions do not rebut Dr. Irani's specific finding of mitral
annular calcification based on his review of Ms. Lee's
March 25, 2010 echocardiogram.

The Trust also argued that

claimant's surgeon may not have noted mitral annular
calcification at the time of claimant's mitral valve surgery
because it was not severe and, in any event, echocardiographic
evidence may be used to determine the presence of mitral annular
calcification.

Finally, the Trust also identified specific loops

on claimant's March 25, 2010 echocardiogram where it maintained
mitral annular calcification was evident.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's March 25, 2010 echocardiogram and concluded that there
was no reasonable medical basis for finding that Ms. Lee did not
have mitral annular calcification.

Specifically, Dr. Vigilante

stated, in pertinent part, that:
Visually, the mitral valve was markedly
abnormal.
There was significant thickening
of the mitral leaflets with restriction of
posterior leaf let excursion and poor
coaptation.
In addition, there was
significantly thickened and increased
reflectance of echoes in the posterior
annulus classic for mitral annular
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calcification. There was obvious
calcification of the posterior mitral annulus
noted on loops 1, 2, 3, 7, 8, 15, 34, 38, 40,
and 50. This was seen in the parasternal
long-axis, parasternal short-axis, and apical
two chamber views.
This was not visualized
adequately in the apical four chamber view
since the posterior annulus is not visualized
in this view.
Dr. Vigilante also reviewed claimant's April 2, 2010 and
April 5, 2010 echocardiograms and concluded that they
demonstrated "classic" mitral annular calcification.
In response to the Technical Advisor Report, claimant
argues that the Technical Advisor ignored the best evidence as to
the presence of mitral annular calcification, namely, the
statement of claimant's surgeon, Dr. Khabbaz.

Claimant again

maintains that the statement of her surgeon alone should entitle
her to Matrix A-1 benefits and contends that Dr. Vigilante is not
qualified to evaluate Dr. Khabbaz's conclusions because
Dr. Vigilante is not a Board-Certified cardiothoracic surgeon.
After reviewing the entire show cause record, we find
claimant's arguments are without merit.

As noted previously, the

Settlement Agreement provides that the presence of mitral annular
calcification requires the payment of reduced Matrix Benefits.
See Settlement Agreement

§

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

The auditing

cardiologist and the Technical Advisor each reviewed claimant's
medical records, including her March 25, 2010; April 2, 2010; and
April 5, 2010 echocardiograms, and concluded that there was no
reasonable medical basis for finding that claimant did not have
mitral annular calcification.

In particular, Dr. Irani stated
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that mitral annular calcification "is certainly present'' in
multiple views on claimant's March 25, 2010 echocardiogram.
Similarly, Dr. Vigilante concluded that "the echocardiograms of
March 25, 2010, April 2, 2010, and April 5, 2010, all show
classic mitral annular calcification limited to the posterior
annulus. " 10
We disagree with claimant that the statements of
Dr. Raskin and the declaration of Dr. Khabbaz establish a
reasonable medical basis for finding that Ms. Lee did not have
mitral annular calcification at the time of her surgery. 11

As an

initial matter, Dr. Khabbaz states that Ms. Lee did not have
mitral annular calcification because he did not note it in his
operative report and he "always describe[s]

in [his] operative

report the presence of any mitral annular calcification because
its presence is very significant to such surgery."

However,

Dr. Irani considered Dr. Khabbaz's declaration and explained that
"[s]uch mild mitral annular calcification would likely not be
noted by a surgeon upon visual inspection, and would not affect

10. Despite claimant's argument, the Technical Advisor did not
ignore the declaration of Dr. Khabbaz.
To the contrary, the
Technical Advisor's Report specifically notes Dr. Khabbaz•s
declaration and that it was reviewed. We also reject claimant's
assertion that only a Board-Certified cardiothoracic surgeon is
competent to evaluate Dr. Khabbaz•s statements with respect to
whether claimant has mitral annular calcification.
11. As the issue is whether Ms. Lee had mitral annular
calcification at any time prior to her surgery, it is irrelevant
that the initial auditing cardiologist did not find mitral
annular calcification on claimant's November 23, 1998
echocardiogram.
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the surgeon's approach to the surgery."

Although claimant

submitted a supplemental statement from Dr. Raskin following
Dr. Irani's second review, neither he nor Dr. Khabbaz addressed
this finding.

Moreover, Dr. Khabbaz did not state that he has an

independent recollection of Ms. Lee's mitral valve, and he did
not state in her operative report that she did not have mitral
annular calcification.
This is particularly true in light of the express
findings of the auditing cardiologist and Technical Advisor.
Notably, Dr. Khabbaz did not express any opinion as to the
presence of mitral annular calcification on any of Ms. Lee's
echocardiograms.

Further, Dr. Raskin only stated that he was

mistaken as to the presence of mitral annular calcification on
claimant's March 25, 2010 echocardiogram.

Significantly,

Dr. Raskin expressed no opinion as to mitral annular
calcification on claimant's April 5, 2010 echocardiogram and, as
to claimant's April 2, 2010 echocardiogram, only stated that it
"revealed no occlusive or severe coronary atherosclerosis."
Under the Settlement Agreement, however, any presence of mitral
annular calcification requires that a mitral valve claim be
reduced to the B Matrix.

See, e.g., Mem. in Supp. of PTO

No. 8421 at 8 (Mar. 10, 2010):

"Unlike some of the other factors

that reduce a claim to Matrix B-1, any presence of [mitral

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annular calcification], regardless of the amount, places the
claim on Matrix B-1.

1112

For the foregoing reasons, we conclude that there is no
reasonable medical basis for finding that claimant did not have
mitral annular calcification prior to her surgery.

Therefore, we

will affirm the Trust's denial of Ms. Lee's claim for Matrix A-1
benefits.

12. We also reject claimant's assertion that "the absence of
significant coronary artery disease . . . related to [mitral
annular calcification] " supports a finding that claimant does not
have mitral annular calcification. There is no requirement under
the Settlement Agreement that a claimant's mitral annular
calcification must be "related" to significant coronary disease.
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