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

Filing 4888

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9141 RE: CLAIMANT KAREN L. CLARK. SIGNED BY HONORABLE HARVEY BARTLE, III ON 9/18/2013; 9/18/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110105 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.

Bartle, J.

q I '-1

September!
Karen L. Clark ("Ms. Clark" or "claimant"), a

I~'

2013

lass

member under the Diet Drug Nationwide Class Action Settl ment
Agreement ("Settlement Agreement") with Wyeth,
from the AHP Settlement Trust ("Trust") . 2

1

seeks be

Based on the

developed in the show cause process, we must determine w ether
claimant has demonstrated a reasonable medical basis to

upport

her claim for supplemental Matrix Compensation Benefits ("Matrix
Benefits") . 3

1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
In 2009, Pfizer, Inc. acquired Wy th.
2. Larry Clark, Ms. Clark's spouse, also has submitted
derivative claim for benefits.
3. Matrix Benefits are paid according to two benefit rna
(Matrix "A" and Matrix "B"), which generally classify cl
for compensation purposes based upon the severity of the
( cont

rices
imants
r
nued ... )

To seek Matrix Benefits, a claimant must firs
completed Green Form to the Trust.
three parts.

submit a

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 t at
correlate to the Matrix criteria set forth in the Settle ent
Agreement.

Finally, claimant's attorney must complete

if claimant is represented.
In January, 2012, claimant submitted a completled Green
Form to the Trust signed by her attesting physician, Manpj R.
Muttreja, M.D.

Based on an echocardiogram dated

I

September 11, 2002, Dr. Muttreja attested in Part II of
Ms. Clark's Green Form that she suffered from moderate mitral
regurgitation and ventricular fibrillation or sustained
ventricular tachycardia which results in hemodynamic

romise.

He also attested that Ms. Clark underwent surgery to

ir or

3.
( ... continued)
medical conditions, their ages when they are diagnosed,
nd the
presence of other medical conditions that also may have aused or
contributed to a claimant's valvular heart disease ("VHD"). See
Settlement Agreement§§ IV.B.2.b. & IV.B.2.d. (1)-(2). M trix A-1
describes the compensation available to Diet Drug Recipi nts 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 he B
matrices applicable.
In contrast, Matrix B-1 outlines t e
compensation available to Diet Drug Recipients with seri us VHD
who were registered as having only mild mitral regurgita ion by
the close of the Screening Period or who took the drugs or 60
days or less or who had factors that would make it diffi ult for
them to prove that their VHD was caused solely by the us of
these Diet Drugs.
-2-

------------------------------,--------------

replace the aortic and/or mitral valve(s) following the use of
Pondimin® and/or Redux™. 4

Based on such findings, claim nt would

be entitled to Matrix A-1, Level V5 benefits in the amou t of
$1,102,453. 6
In the report of claimant's echocardiogram, t e
reviewing cardiologist, David M. Gonzalez, M.D., noted that
claimant had moderate mitral regurgitation, which he me
be 26%.

to

Under the definition set forth in the Settleme

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 ("
See Settlement Agreement

§

I. 22.

").
I

In March, 2012, the Trust forwarded the claim for
review by Zuyue Wang, M.D., F.A.C.C., F.A.S.E., one of its
auditing cardiologists.

In audit, Dr. Wang concluded t at there

4.
In addition, Dr. Muttreja attested that claimant suffered
from an abnormal left atrial dimension.
This condition is not at
issue in this claim.
5. Under the Settlement Agreement, a claimant is entitled to
Level V benefits if he or she qualifies for Level III be efits
and suffers from ventricular fibrillation or sustained
ventricular tachycardia which results in hemodynamic co
See Settlement Agreement § IV.B.2.c. (5) (d). A claimant
entitled to Level III benefits if he or she suffers fro
sided valvular heart disease requiring ... [s]urgery to
or
replace the aortic and/or mitral valve(s) following the
Pondimin® and/or Redux™." Id. § IV.B.2.c. (3) (a).
6. Ms. Clark previously was paid Seventh Amendment Cate ory One
benefits. Thus, if Ms. Clark's supplemental claim forM trix
A-1, Level V benefits is payable, she only will receive the
amount that exceeds the previous payment she received.
Settlement Agreement § IV.C.3.
-3-

was no reasonable medical basis for the attesting physician's
finding that claimant had moderate mitral regurgitation because
her echocardiogram demonstrated only mild regurgitation. 7

In

support of this conclusion, Dr. Wang explained that "[t]he
RJA/LAA ratio was 18% (3.7/21).

The RJA encircled should not

include the area of low velocity flow."

Dr. Wang also concluded

that there was no reasonable medical basis for the attesting
physician's finding that Ms. Clark had ventricular fibrillation
or sustained ventricular tachycardia which results in he odynamic
compromise.

In support of this conclusion, Dr. Wang explained,

"The claimant had one episode of ventricular fibrillatio
requiring defribrillation [sic] Xl during bypass surgery.
was taken to ICU in stable condition.

[S] he

There is no docum nted

evidence of hemodynamic instability associated with [ven ricular]
[fibrillation] . " 8

7. Under the Settlement Agreement, mild mitral regurgit
defined as "(1) either RJA/LAA ratio is more than five p
(5%) or the mitral regurgitation jet height is greater t
from the valve orifice, and (2) the RJA/LAA is less than
percent (20%) ." Settlement Agreement§ I.38.

tion is
rcent
an 1 em
twenty

8. Dr. Wang, however, did determine that there was are
medical basis for the attesting physician's finding that
Ms. Clark underwent surgery to repair or replace the aor
and/or mitral valve(s) following the use of Pondimin® an
Redux™.
In support of this conclusion, Dr. Wang explain
"[t]he claimant filled prescriptions for Pondimin and Ph
in July, August, 1996. She underwent mitral valve repai
[coronary artery bypass graft] on 10/31/08."

sonable

-4-

ic
/or
d that
ntermine
and

Pursuant to Court Approved Procedure ("CAP")

11,

the Consensus Expert Panel 9 subsequently reviewed Ms. Cl rk's
claim to determine whether the audit of her claim
with our decision in PTO No. 8624 (Mar. 9, 2011).

The

onsensus

Expert Panel determined Ms. Clark's claim should not be
re-audited because, "Ventricular fibrillation occurring during
separation from cardiopulmonary bypass is a frequent

t,

rather than indicating increased medical severity as

taneous

ventricular fibrillation does.

irement

However, there is no

for demonstrating hemodynamic compromise with ventricula
fibrillation."
Thus, based on the auditing cardiologist's fin ings,
the Trust issued a post-audit determination that claiman

was

entitled only to Matrix B-1, 10 Level III benefits.
the Rules for the Audit of Matrix Compensation Claims (" udit
Rules"), claimant contested this adverse determination. 1

9.
The Consensus Expert Panel consists of three cardiol
one designated by each of Class Counsel, the Trust, and
See Pretrial Order ("PTO") No. 6100 (Mar. 31, 2006). We
creation of the Consensus Expert Panel to "monitor the
performance of the Auditing Cardiologists and to develop
procedures for quality assurance in the Audit of Claims
Matrix Compensation Benefits." Id.

In

gists,
yeth.
approved
or

10. The Settlement Agreement requires the payment of re
Matrix Benefits to a claimant who is diagnosed with mild
regurgitation by an echocardiogram, like Ms. Clark's
September 11, 2002 echocardiogram here, which was perfor ed
between the commencement of Diet Drug use and the end of the
Screening Period. See Settlement Agreement § IV.B.2.d. ( ) (a) .
11.

Claims placed into audit on or before December 1, 2 02 are
(cont · nued ... )
-5-

contest, claimant argued that there was a reasonable me
basis for Dr. Muttreja's Green Form representation that

Clark

suffered from moderate mitral regurgitation and ventric
fibrillation.

With respect to her level of mitral regu

claimant submitted:

Dr. Gonzalez's report of her echoc rdiogram;

a March 28, 2006 letter from the Seventh Amendment Fund
Administration, which indicated an RJA/LAA ratio of 26.12%; and
declarations of Leon J. Frazin, M.D., F.A.C.C., and Paul W.
Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A., each of who

reviewed

claimant's echocardiogram and determined it demonstrated moderate
mitral regurgitation.

With respect to her ventricular

fibrillation, claimant contended that she is not require

to

prove that ventricular fibrillation, which the auditing
cardiologist found, resulted in hemodynamic compromise.

In

addition, Ms. Clark submitted a declaration of Robert L.
Rosenthal, M.D., wherein he stated that "intraoperative
ventricular fibrillation is an adverse event which harms the
myocardium and results in measurable changes in cardiac

nzymes

and cardiac output."
Although not required to do so, the Trust forw rded the
claim for a second review by the auditing cardiologist.

Dr. Wang

11.
( ... continued)
governed by the Policies and Procedures for Audit and Di
of Matrix Compensation Claims in Audit, as approved in P
No. 2457 (May 31, 2002). Claims placed into audit after
December 1, 2002 are governed by the Audit Rules, as app oved in
PTO No. 2807 (Mar. 26, 2003). There is no dispute that
Audit
Rules contained in PTO No. 2807 apply to Ms. Clark's cla'm.
-6-

submitted a declaration in which she again determined th t there
was no reasonable medical basis for the attesting physician's
representations that claimant had moderate mitral regurgitation
or ventricular fibrillation or sustained ventricular tac ycardia
which resulted in hemodynamic compromise.

Dr. Wang stat d, in

relevant part, that:
12.

With regard to mitral regurgitation, at
Contest, I reviewed the contest
materials including the Declarations of
Drs. Dlabal and Frazin.
I determined
that the mitral regurgitation seen on
Claimant's September 11, 2002
echocardiogram of attestation is mild.
First, the encircled RJA improperly
included low velocity flow, which is
dark blue in color, instead of green
mosaic color representing true mitral
regurgitation.
Second, the mitral
regurgitation seen on the study occurs
at the end of QRS, when the mitral valve
suddenly closes and pushes mitral inflow
back into left atrium (i.e., back flow.)
Therefore, a significant part of the
mitral regurgitation seen on the study
is backflow, rather than true mitral
regurgitation.
Finally, the continuous
wave Doppler shows that mitral
regurgitation occurs at the beginning of
systole, and does not continue through
systole.
For all these reasons, I
confirm that there is no reasonable
medical basis to conclude that Claimant
had moderate mitral regurgitation.

13.

With regard to ventricular fibrillation
or sustained ventricular tachycardia
resulting in hemodynamic compromise, at
Contest I reviewed Dr. Rosenthal's
declaration and accompanying articles.
According to the literature provided by
Dr. Rosenthal, ventricular fibrillation
after release of the aortic cross-clamp
in patients undergoing cardiac surgery
is reported to occur in 74% to 100% of
cases.
This Claimant developed
-7-

ventricular fibrillation after the
release of the aortic cross clamp for
which she received a single
defibrillation without recurrence.
There was no documented elevation of
cardiac markers or LV dysfunction
requiring any additional pressors or
mechanical support. Claimant's records
did not document any additional episode
of ventricular fibrillation.
Consistent
with the recommendations of the CEP, the
ventricular fibrillation experienced by
the Claimant when separating from the
bypass pump immediately after surgery
does not indicate increased medical
severity beyond that which required
surgery.
The Trust then issued a final post-audit dete
again denying Ms. Clark's claim.

ination,

Claimant disputed this final

determination and requested that the claim proceed to the show
cause process established in the Settlement Agreement.
Settlement Agreement§ VI.E.7.; PTO No. 2807; Audit
The Trust then applied to the court for issuance of an
show cause why Ms. Clark's claim should be paid.

On

November 19, 2012, we issued an Order to show cause and
the matter to the Special Master for further proceedings.

See

PTO No. 8968 (Nov. 19, 2012).
Once the matter was referred to the Special Ma ter, 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 March 14, 2013,

Audit Rules, it is within the Special Master's discretio

-8-

nd

to

appoint a Technical Advisor 12 to review claims after the Trust
and claimant have had the opportunity to develop the Sho
Record.

See Audit Rule 30.

The Special Master assigne

Cause
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 in proving that ther

is a

reasonable medical basis for the attesting physician's finding
that she had moderate mitral regurgitation and suffered
ventricular fibrillation.

See id. Rule 24.

Ultimately, if we

determine that there is no reasonable medical basis for

he

answers in claimant's Green Form that are at issue,

st

affirm the Trust's final determination and may grant sue
relief as deemed appropriate.

See id. Rule 38(a).

If,

other hand, we determine that there is a reasonable

other
n the
al basis

for the answers, we must enter an Order directing the Tr st to
pay the claim in accordance with the Settlement Agreemen

See

id. Rule 38(b).

12. A "[Technical] [A]dvisor's role is to act as a soun
board for the judge--helping the jurist to educate himse
jargon and theory disclosed by the testimony and to thin
the critical technical problems." Reill v. United Stat
F.2d 149, 158 (1st Cir. 1988).
In a case such as this,
conflicting expert opinions exist, it is within the disc
the court to appoint a Technical Advisor to aid it in re
technical issues.
Id.
-9-

ing
f in the
through
s, 863
here
etion of
olving

In support of her claim, Ms. Clark reasserts
arguments she made in contest, namely, that there is a

easonable

medical basis for Dr. Muttreja's Green Form representat'on that
claimant had moderate mitral regurgitation and ventricu
fibrillation.

In addition, she submitted supplemental

declarations from Dr. Frazin and Dr. Dlabal.

In his su

declaration, Dr. Frazin stated, in pertinent part, that:
3.

Dr. Wang claimed that "the encircled RJA
improperly included low velocity flow,
which is dark blue in color, instead of
green mosaic color representing true
mitral regurgitation." This claim is
incorrect. Numerous frames show that
high velocities at the Nyquist limit are
immediately proximal to the mitral
valve. The color code for the
velocities at the Nyquist limit is
greenish in appearance.

4.

Dr. Wang also claimed that "a
significant part of the mitral
regurgitation is backflow, rather than
true mitral regurgitation." This claim
is also incorrect. Mitral valve
backflow has velocities lower than the
Nyquist limit.
In this case, the
moderate MR jets are high velocity jets
and they are at the Nyquist limit.

5.

Also, velocities observed from backflow
are due to blood immediately on the left
atrial side of an INTACT mitral valve
being pushed away from the transducer
during ventricular systole.
In this
case, the high velocity jets indicate an
INCOMPETENT mitral valve. These high
velocity jets are true regurgitant jets
and they are not backflow.

6.

Dr. Wang also
regurgitation
QRS complex.
occurs during
at the end of

claimed that mitral
occurred at the end of the
That is impossible. MR
systole.
It cannot occur
the QRS, because that
-10-

period of the cardiac cycle is still
diastole.
7.

Lastly, Dr. Wang claimed that MR
occurred at the beginning of systole and
did not continue throughout systole.
It
only appears that way because the
continuous wave Doppler was not properly
aligned with the mitral regurgitant jet.
Therefore, the continuous wave Doppler
cannot show that MR continued throughout
systole. Nevertheless, the high
velocity jets described above had to
occur during systole, when the aortic
valve was open and the mitral valve had
attempted to close.

In his supplemental declaration, Dr. Dlabal stated, in p rtinent
part, that:
3.

In her declaration, Dr. Wang claimed
that "First, the encircled RJA
improperly included low velocity flow,
which is dark blue in color, instead of
green mosaic color representing true
mitral regurgitation." This claim is
completely incorrect. True mitral
regurgitation (MR) is blue, or deep
blue, by color flow Doppler signal.
Blue-green signal, or "mosaic" would be
yet a more severe case of MR, but need
not be present for the existence of MR.
In each case where MR was assessed, the
left atrium (LA) was more than 20%
filled, often up to 50% filled, with
deep blue signal indicating significant
regurgitation. While some (but not all)
images were "generously" traced, I
excluded these or adjusted for the
excess tracings in making the
calculations found in my original
declaration.

4.

"Low velocity flow" was not included in
the assessment of MR in this case.
There was no low velocity flow found on
the edges of the clinically significant
jets.
Instead, low velocity flow, where
present, is faint and encompasses less
than 5% of the LAA.
In essence, the
-11-

Settlement Agreement and Part II of the
Green Form acknowledge the existence of
low velocity flow, and these authorities
dispense with it by restricting the
diagnostic criteria for at least mild MR
to 6% RJA/LAA or greater. That all jets
assessed were > than 20% effectively
eliminates the possibility of including
low velocity flow.
5.

Secondly, Dr. Wang claimed that "· .. the
mitral regurgitation seen on the study
occurs at the end of QRS, when the
mitral valve suddenly closes and pushes
mitral inflow back into left atrium
(i.e. back flow.)" This claim is also
incorrect. The moderate to severe jets
are not backflow, for the reasons
described above.
Further, the
technician was careful to insure that
the signal measured included images from
at least 0.16-0.20 seconds (or more)
after the onset of the QRS complex.
In
essence, this captures MR signal from
mid-systole, when MR should be maximal,
if present at all, and further excludes
(early) physiologic backflow, which
would occur just after the onset (not
the end) of mechanical LV contraction,
or about 0.06 seconds after the onset of
the QRS complex.
(Note, at normal heart
rates, the entire QRS complex through
the T-wave, i.e. ventricular contraction
and relaxation, lasts only 0.34-0.43
seconds.)

6.

Lastly, Dr. Wang alleged that " ... the
continuous wave Doppler shows that
mitral regurgitation occurs at the
beginning of systole, and does not
continue through systole." While we can
agree that there is a large "pulse" of
MR in the first ~ of systole, as seen by
continuous wave (CW) Doppler, this does
not negate the findings above, but is
rather a function of the duration of MR
(months vs. years), extent of the actual
lesion involving the MR, ability of the
LA to dilate (this one had not, as of
the time of the study) as well as the
orientation of the Doppler beam by the
-12-

technician (CW provides only an "ice
pick" view of a larger signal) .
Clinically, CW Doppler has no bearing on
the assessment of severity of MR, for
which the criteria are established using
color flow (CF) Doppler only (not CW
Doppler) ; these criteria have been
accepted by the Settlement Agreement and
applied to the Green Form Part II as
well.
In response, the Trust argues that the issue is whether
there is a reasonable medical basis for the attesting p
findings, not which party can collect more opinions.

sician's

With

respect to claimant's level of mitral regurgitation, the Trust
contends that the auditing cardiologist reviewed claimant's
echocardiogram and determined that "'a significant part

f the

mitral regurgitation seen on the study is backflow, rath r than
true mitral regurgitation.'"
fibrillation,

With respect to ventricula

the trust reasserts that the conclusions o

the

Consensus Expert Panel and Dr. Wang, namely, that claima t's
ventricular fibrillation occurred in connection with her
valve repair surgery and does not demonstrate increased

edical

severity.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's September 11, 2002 echocardiogram and conclud d that
there was a reasonable medical basis for the attesting
physician's finding that claimant had moderate mitral
regurgitation.

Specifically, Dr. Vigilante determined t at:

Visually, mild to moderate mitral
regurgitation was present.
I digitized the
cardiac cycles in the apical views in which
the mitral regurgitant jet was best
-13-

evaluated. This jet was mostly noted in the
early and mid phases of systole and was
minimal during the latter part of systole.
I
digitally traced and calculated the RJA and
LAA.
I was able to accurately planimeter the
RJA in the mid-portion of systole.
The
largest representative RJA in the apical four
chamber view was 4.5 cm2. The LAA in the
apical four chamber view was 21.6 cm2.
Therefore, the largest representative RJA/LAA
ratio in the apical four chamber view was 21%
qualifying for moderate mitral regurgitation
After reviewing the entire Show Cause Record,

e find

that claimant has established a reasonable medical basis for her
claim.

First, we find that claimant has established a reasonable

medical basis for finding that her echocardiogram demonstrates
moderate mitral regurgitation.

In connection with her r view of

Ms. Clark's claim, the auditing cardiologist determined that
claimant's echocardiogram demonstrated only mild mitral
regurgitation because (1) the RJA measurement improperly included
low velocity flow and (2) a significant part of the mitr 1
regurgitation seen on the study is backflow, rather than true
mitral regurgitation.
Ms. Clark disputed these findings.

In additio

to the

findings of Dr. Gonzalez and the Seventh Amendment Parti ipating
Physician, each of whom found that claimant's echocardio
demonstrated moderate mitral regurgitation with an RJA/
26%, claimant submitted declarations of Dr. Frazin and
Dr. Dlabal.

In their declarations, Dr. Frazin and Dr.

explained that neither low velocity flow nor backflow co
any part of their determination that claimant had modera

-14-

of

regurgitation.

Moreover, Dr. Vigilante reviewed claiman 's

echocardiogram and determined that it demonstrated moder te
mitral regurgitation. 13

Thus, we find that claimant has

established a reasonable medical basis for finding that

er

echocardiogram demonstrates moderate mitral regurgitatio
Second, we find that claimant has established
reasonable medical basis for finding that she suffered
ventricular fibrillation or sustained ventricular tachyc rdia
which results in hemodynamic compromise.

We previously

ave

rejected the Trust's argument that ventricular fibrillat'on must
occur spontaneously to be compensable under the Settleme t
Agreement.

Specifically, in PTO No. 8624, we held that

Trust's argument that claimant was not entitled to

he

v

benefits because the ventricular fibrillation she experi need was
"not spontaneous, but rather 'was induced by manipulatio

of the

heart ... during surgery'" improperly required proof of
causation.

Mem. in Supp. of PTO No. 8624, at 17-18

(Mar. 9, 2011); see also Mem. in Supp. of PTO No. 9072,
(May 3 0 , 2 0 13 ) .
For the foregoing reasons, we conclude that cl imant
has met her burden of proving that there is a reasonable medical
basis for her claim.

Therefore, we will reverse the Tru t's

denial of Ms. Clark's claim for Matrix A-1, Level V bene its and
the related derivative claim submitted by her spouse.

13. Despite an opportunity to do so, the Trust did not ubmit a
response to the Technical Advisor Report.
See Audit Rul 34.
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