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

Filing 4246

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 8654 RE: CLAIMANT GEORGIA J. LANG. SIGNED BY HONORABLE HARVEY BARTLE, III ON 7/19/2011; 7/20/2011 ENTERED AND COPIES MAILED AND E-MAILED. (SEE PAPER # 109443 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
)
___________________________________)
)
THIS DOCUMENT RELATES TO:
)
)
SHEILA BROWN, et al.
)
)
v.
)
)
AMERICAN HOME PRODUCTS
)
CORPORATION
)

MDL NO. 1203

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

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.
Bartle, J.

July 19, 2011
Georgia J. Lang ("Ms. Lang" 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").2

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. Leo Lang, Ms. Lang'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
contributed to a claimant's valvular heart disease ("VHD"). See
(continued...)

To seek Matrix Benefits, a claimant must 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 in the Settlement Agreement.
Finally, claimant's attorney must complete Part III if claimant
is represented.
In November, 2002, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Richard
Callihan, M.D., F.A.C.C.

Based on an echocardiogram dated

August 1, 2002, Dr. Callihan attested in Part II of Ms. Lang's
Green Form that she suffered from moderate mitral regurgitation
and an abnormal left atrial dimension.

Based on such findings,

3. (...continued)
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.
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claimant would be entitled to Matrix A-1, Level II benefits in
the amount of $496,153.4
In the report of claimant's echocardiogram, the
reviewing cardiologist, Marcus Brann, M.D., F.A.C.C., F.A.C.P.,
stated, "The mitral valve is anatomically normal but demonstrates
moderate regurgitation."

Dr. Brann, however, did not specify a

percentage as to the level of claimant'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").
Agreement § I.22.

See Settlement

Dr. Brann also stated that claimant had "mild

left atrial enlargement."

Specifically, Dr. Brann determined

that Ms. Lang's left atrial dimension measured 65 mm in the left
atrial supero-inferior systolic dimension and 41 mm in the left
atrial antero-posterior systolic dimension.

The Settlement

Agreement defines an abnormal left atrial dimension as a left
atrial supero-inferior systolic dimension greater than 5.3 cm in
the apical four chamber view or a left atrial antero-posterior

4. Under the 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). An abnormal left
atrial dimension is one of the complicating factors needed to
qualify for a Level II claim.
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systolic dimension greater than 4.0 cm in the parasternal long
axis view.

See id. § IV.B.2.c.(2)(b).
In August, 2006, the Trust forwarded the claim for

review by Siu-Sun Yao, M.D., F.A.C.C., one of its auditing
cardiologists.5

In audit, Dr. Yao concluded that there was no

reasonable medical basis for Dr. Callihan's finding that claimant
had moderate mitral regurgitation because claimant's
echocardiogram demonstrated only mild mitral regurgitation.
Dr. Yao explained:
[T]echnical setting incorrect. [N]yquist
limit 51, later in [echocardiogram] study
decreased to 46. [S]onographer incorrect
tracing of mitral regurgitation - RJA; should
not include trace of low velocity non
regurgitant flow. 2+ [mitral regurgitation]
seen in real time echocardiogram.
Dr. Yao also found that there was no reasonable medical basis for
the attesting physician's finding that claimant had an abnormal

5. The Trust originally forwarded Ms. Lang's claim for review in
or around March, 2004. The auditing cardiologist agreed with
Dr. Callihan's Green Form representations, but the Trust later
determined that the echocardiogram included inserted frames.
Pursuant to Pretrial Order ("PTO") No. 5517 (July 27, 2005),
claimant elected to have the inserted frames removed and the
claim re-audited. Thus, in March, 2006, the Trust forwarded
Ms. Lang's claim, including the redacted echocardiogram, for
audit. Although the auditing cardiologist again agreed with
Dr. Callihan's Green Form representations, the Trust submitted
the claim for review by the Consensus Expert Panel ("CEP")
pursuant to PTO No. 6100 (Mar. 31, 2006) (adopting Court Approved
Procedure No. 11 ("CAP 11")). Based on the recommendation of the
CEP, Ms. Lang's claim and redacted echocardiogram were submitted
to another auditing cardiologist, Dr. Yao, for review. Dr. Yao's
review is the subject of this show cause proceeding.
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left atrial dimension, concluding that the "left atrial dimension
[was] not increased."

Specifically, Dr. Yao measured claimant's

left atrial dimension as 52 mm in the left atrial supero-inferior
systolic dimension and 39 mm in the left atrial antero-posterior
systolic dimension.
Based on Dr. Yao's findings, the Trust issued a postaudit determination denying Ms. Lang's claim.

Pursuant to the

Rules for the Audit of Matrix Compensation Claims ("Audit
Rules"), claimant contested this adverse determination.6

In

contest, claimant argued that there was a reasonable medical
basis for her claim because, although the auditing cardiologist
found mild mitral regurgitation, he observed that "2+ [mitral
regurgitation was] seen in real time."

Ms. Lang also asserted

that she should prevail because the results of the Trust's reaudit of her claim pursuant to PTO No. 5517 were consistent with
the results of the initial, favorable audit.

According to

claimant, the results of the audit by Dr. Yao should be "thrown
out" because his review constituted an impermissible third audit.
The Trust then issued a final post-audit determination
again denying Ms. Lang's claim.

Claimant disputed this final

6. 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. Lang's claim.
-5-

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. Lang's claim should be paid.

On

January 22, 2007, we issued an Order to show cause and referred
the matter to the Special Master for further proceedings.
See PTO No. 6873 (Jan. 22, 2007).
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 April 13, 2007.

Under

the Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor7 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, 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

7. 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.
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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 there is a
reasonable medical basis for the attesting physician's findings
that she had moderate mitral regurgitation and an abnormal left
atrial dimension.

See id. Rule 24.

Ultimately, if we determine

that there is no reasonable medical basis for the answers in
claimant's Green Form that are 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
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 her claim, claimant states that she
"disagrees with the medical findings of the Auditing Cardiologist
and the Trust's characterization of those medical findings."

In

response, the Trust argues that claimant has not established a
reasonable medical basis for her claim because she did not rebut
Dr. Yao's specific findings that claimant's attesting physician
relied on improper echocardiogram settings and included nonregurgitant flow in his measurement of claimant's level of mitral
regurgitation.

Finally, the Trust contends that the claim and

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redacted echocardiogram were properly submitted for re-audit
pursuant to CAP 11.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's echocardiogram and concluded that there was a
reasonable medical basis for the attesting physician's findings
of both moderate mitral regurgitation and an abnormal left atrial
dimension.

Specifically, Dr. Vigilante stated in reference to

the level of claimant's mitral regurgitation that:
I was able to digitally trace and calculate
the RJA and LAA in the apical two chamber
view. Although there was increased color
gain, the Nyquist limit was more
appropriately set at 51 cm per second at a
depth of 19 cm in the apical two chamber
view. I was able to determine an accurate
RJA in the mid portion of systole. The worst
representative RJA in the apical two chamber
view was 4.6 cm2. I determined that the LAA
in this view was 20.2 cm2. Therefore, the
worst representative RJA/LAA ratio in the
apical two chamber view was 23%. This
qualified for moderate mitral regurgitation.
* * *
... [T]here is a reasonable medical basis for
the Attesting Physician's answer to Green
Form Question C.3.a. That is, the
echocardiographic study of August 1, 2002
demonstrated moderate mitral regurgitation
with comments as above.
With respect to claimant's left atrial dimension, Dr. Vigilante
found that:
Visually, the left atrium appeared mildly
dilated. I digitized the cardiac cycles in
the parasternal long-axis and apical four
chamber views in which the left atrium
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appeared the largest. I measured the left
atrium by electronic calipers. I determined
that the left atrial antero-posterior
diameter was 4.0 cm. This measurement was
taken between the posterior root of the aorta
and posterior left atrial wall at the level
of the aortic valve. This line was
perpendicular to the supero-inferior axis of
the left atrium. The sonographer's largest
left atrial diameter in the parasternal longaxis view was 4.14 cm. This was an
inaccurate determination as this measurement
was taken on a diagonal within the left
atrium. I determined that the left atrium
measured 5.5 cm in the supero-inferior
dimension. This measurement was taken from
the mitral annulus to the posterior left
atrial wall. This measurement was
perpendicular to the mitral annulus. I
excluded pulmonary vein structures in this
measurement. My LAA determination of
24.5 cm2 in the apical four chamber view is
also consistent with mild left atrial
enlargement.
* * *
... [T]here is a reasonable medical basis for
the Attesting Physician's answer to Green
Form Question F.5. That is, the
echocardiographic study of August 1, 2002
demonstrated an abnormal left atrial
dimension supero-inferior axis with comments
as above.
After reviewing the entire Show Cause Record, we find
that claimant has established a reasonable medical basis for her
claim.

Both the attesting physician and the reviewing

cardiologist found that claimant's echocardiogram demonstrated
moderate mitral regurgitation and an abnormal left atrial
dimension.

The Trust, based on Dr. Yao's findings that the

sonographer used an inappropriate Nyquist limit and included
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trace low velocity and non-regurgitant flow, challenged the
attesting physician's findings.
Dr. Vigilante reviewed the echocardiogram.

Although he

confirmed that the sonographer used an inappropriate Nyquist
limit and included low velocity and non-regurgitant flow,
Dr. Vigilante nevertheless determined that the echocardiogram
demonstrated moderate mitral regurgitation and an abnormal left
atrial dimension.8

Specifically, Dr. Vigilante measured an

RJA/LAA ratio of 23% and found that the left atrium "measured
5.5 cm in the supero-inferior dimension."
As stated above, moderate or greater mitral
regurgitation is present where the RJA in any apical view is
equal to or greater than 20% of the LAA.
Agreement § I.22.

See Settlement

Dr. Callihan, Dr. Brann, and Dr. Vigilante

each found that claimant's echocardiogram demonstrated an RJA/LAA
ratio greater than 20%.

Moreover, an abnormal left atrial

dimension is present when the left atrial supero-inferior
systolic dimension is greater than 5.3 cm in the apical four
chamber view or the left atrial antero-posterior systolic
dimension is greater than 4.0 cm in the parasternal long axis
view.

See id. § IV.B.2.c.(2)(b).

Dr. Callihan, Dr. Brann, and

Dr. Vigilante also each found that claimant's echocardiogram

8. Despite an opportunity to do so, the Trust did not submit a
response to the Technical Advisor Report. See Audit Rule 34.
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demonstrated a left atrial supero-inferior systolic dimension
greater than 5.3 cm in the apical four chamber view.

Thus,

claimant has established that her echocardiogram demonstrates
moderate mitral regurgitation and an abnormal left atrial
dimension as defined by the Settlement Agreement.9
For the foregoing reasons, we conclude that claimant
has met her burden of proving that there is a reasonable medical
basis for her claim and that she consequently is entitled to
Matrix A-1, Level II benefits.

Therefore, we will reverse the

Trust's denial of Ms. Lang's claim for Matrix Benefits and the
related derivative claim submitted by her spouse.

9. Given our resolution, we need not address claimant's
remaining arguments.
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