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

Filing 4647

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9000 RE: CLAIMANT JOYCE DAVIS. SIGNED BY HONORABLE HARVEY BARTLE, III ON 1/31/2013; 2/1/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109864 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

)

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_____________________________________ )
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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.

q000

January ~l , 2013

Bartle, J.

Joyce Davis ("Ms. Davis" or "claimant"), a class member
under the Diet Drug Nationwide Class Action Settlement Agreement
("Settlement Agreement") with Wyeth,
Settlement Trust ("Trust").

1

seeks benefits from the AHP

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 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 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 November, 2003, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Milton D.
Concannon, M.D.

Based on an echocardiogram dated

December 14, 2002, Dr. Concannon attested in Part II of
claimant's Green Form that Ms. Davis suffered from moderate
mitral regurgitation and an abnormal left atrial dimension.
Based on such findings, claimant would be entitled to Matrix A-1,
Level II benefits in the amount of $207,947. 3

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. 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
(continued ... )
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In the report of claimant•s echocardiogram,
Dr. Concannon stated,
regurgitation ...

11

There is moderate (26%") mitral

Under the definition set forth in the Settlement

Agreement, moderate or greater mitral regurgitation is present
where the Regurgitant Jet Area ( 11 RJA 11

),

in any apical view, is

equal to or greater than 20%" of the Left Atrial Area ( 11 LAA 11 ) .
See Settlement Agreement

§

I.22.

In March, 2004, the Trust forwarded the claim for
review by Qahtan Malki, M.D., F.A.C.C., one of its auditing
cardiologists.

In audit, Dr. Malki concluded that there was no

reasonable medical basis for Dr. Concannon•s finding that
claimant had moderate mitral regurgitation.

Dr. Malki explained:

The LA is clearly enlarged.
One of the
measurements is 27 cm2, the [9ther] one from
the apical 2 chambers is 21cm2.
It is hard
to see the atrium borders from this view.
The [mitral regurgitant] jet was overmeasured
from [one] of the views.
The other jets are
probably little oversized but close enough.
I do not see any turbulent jet with the
[mitral regurgitation] , which makes me think
it is not as severe. [I] think the [mitral
regurgitation] is mild but close to 20%".
Maybe 18%. Better quality study may show
more [mitral regurgitation] .
Based on Dr. Malki•s diagnosis of mild mitral
regurgitation, the Trust issued a post-audit determination

3 ( ... continued)
five complicating factors delineated in the Settlement Agreement.
See Settlement Agreement § IV.B.2.c. (2) (b). As the Trust does
not contest the attesting physician•s finding of an abnormal left
atrial dimension, which is one of the complicating factors needed
to qualify for a Level II mitral valve claim, the only issue is
claimant•s level of mitral regurgitation.
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denying this claim.

Pursuant to the Rules for the Audit of

Matrix Compensation Claims ("Audit Rules"), claimant contested
this adverse determination. 4

In contest, claimant argued that

Dr. Malki should have declared the echo was not susceptible to
evaluation pursuant to Rule 7 of PTO No. 2807 or deferred to the
finding of the attesting physician since he could not determine
with certainty whether the regurgitation was mild or moderate and
because he indicated a "better quality study may show more
[mitral regurgitation]."

Further, claimant stated that she

"contest[ed] all findings contrary to Dr. Concannon's findings,
and maintains that the claimant to [sic] has moderate mitral
valve regurgitation which qualifies as a matrix claim."
The Trust then issued a final post-audit determination
again denying the claim.

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 this claim should be paid.

On August 2, 2006, we

issued an Order to show cause and referred the matter to the

4.
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 Pretrial
Order ("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 this
claim.
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Special Master for further proceedings.

See PTO No. 6455

(Aug. 2, 2 0 0 6) .
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 October 23, 2006.

Under

the Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor 5 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

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 finding
that she had moderate mitral regurgitation.

See id. Rule 24.

Ultimately if we determine that there is no reasonable medical

5. 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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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, claimant reasserts many of the
arguments raised during contest, namely, that Dr. Malki should
have declared that he could not evaluate the December 2002
echocardiogram or should have deferred to Dr. Concannon's
interpretation because Dr. Malki was unable to determine with
certainty whether claimant had mild or moderate mitral
regurgitation.

In addition, she argues that Dr. Concannon's

interpretation is entitled to more weight than Dr. Malki because
Dr. Concannon's involvement in "Phen-Fen" is limited.
In response, the Trust argues that claimant failed to
establish a reasonable medical basis for her claim because she
did not rebut the auditing cardiologist's findings that the left
atrium was "overmeasured" and that there was no turbulent jet
with the mitral regurgitation.

In addition, the Trust contends

that the RJA was measured early in systole consistent with
backflow and included non-regurgitant flow.

The Trust also

asserts that Dr. Malki specifically found that claimant's
echocardiogram was evaluable.

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The Technical Advisor, Dr. Vigilante, reviewed
claimant's echocardiogram and concluded that there was no
reasonable medical basis for the attesting physician's finding
that claimant had moderate mitral regurgitation.

Specifically,

Dr. Vigilante stated that:
In this study, the mitral valve was
structurally normal with thin leaflets that
moved normally. There was no evidence of
mitral valve prolapse nor mitral annular
calcification.
In the parasternal long-axis
view, a thin central jet of mitral
regurgitation was noted. Mitral
regurgitation was also noted in the apical
four chamber and two chamber views.
Visually, the degree of mitral regurgitation
appeared to be mild in these views.
I
digitized those representative cardiac cycles
in which the mitral regurgitation appeared
most impressive in the apical four chamber
and apical two chamber views.
I then
digitally traced and calculated the RJA and
LAA. The LAA was 27.3 cm2 in the apical four
chamber view. The largest RJA/LAA ratio in
the apical four chamber view was less than
11%.
In the apical two chamber view, the
accurate LAA was 21.0 cm2. The accurate RJA
was 2.0 cm2. Therefore, the RJA/LAA ratio in
the apical two chamber view was less than
10%. Most of the RJA/LAA ratios were less
than 8% during this study qualifying for mild
mitral regurgitation. There was no RJA/lAA
ratio that came close to approaching 20%.
I reviewed the measurements made by the
sonographer on the tape ... The sonographer
measured two RJA's in the apical four chamber
view. These measurements were 4.27 cm2 and
4.99 cm2. The measurement of 4.27 cm2
included a great deal of low velocity and
non-mitral regurgitant flow and was
completely inaccurate. The sonographer's RJA
measurement of 4.99 cm2 in the apical four
chamber view was a measurement of backflow
and not mitral regurgitation. The
sonographer also measured an RJA of 5. 69. cm2
in the apical two chamber view. This was an
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inaccurate measurement of backflow and not
mitral regurgitation.
The representative RJA
in the apical four chamber view was 2.9 cm2
and the representative RJA measurement in the
apical two chamber view is 2.0 cm2.
The
Attesting Physician used the sonographer's
inaccurate RJA measurement of 5.69 cm2 in
determining that the RJA/lAA ratio was 26%.
In response to the Technical Advisor Report, claimant
reasserts her arguments regarding the auditing cardiologist's
alleged uncertainty that she raised in contest.

Claimant also

argues that Dr. Vigilante's reading of the December 14, 2002
echocardiogram was "grossly different from the other two doctors"
and thus should be "totally disregarded."
After reviewing the entire Show Cause Record, we find
claimant's

argum~nts

are without merit.

First, claimant does not

adequately contest Dr. Malki's and Dr. Vigilante's specific
findings.

In particular, Dr. Malki determined that claimant's

mitral regurgitant jet area was "overmeasured" in at least one
view. 6

In addition, Dr. Vigilante determined that the

sonographer's measurements included low velocity and non-mitral
regurgitant flow.

Mere disagreement with the auditing

cardiologist and Technical Advisor without identification of
specific errors by them is insufficient to meet a claimant's
burden of proof.
We also disagree with claimant's assertion that
Dr. Concannon's interpretation should be given greater weight.

6.
For this reason as well, we disagree with Ms. Davis that Dr.
Malki was obligated to find the echocardiogram of attestation was
uninterpretable.
-8-

We are required to apply the standards delineated in the
Settlement Agreement and the Audit Rules.

The context of these

two documents leads us to interpret the "reasonable medical
basis" standard as more stringent than claimant contends, and one
that must be applied on a case-by-case basis.

As we previously

explained in PTO No. 2640, conduct "beyond the bounds of medical
reason" can include:
still frames;

(1) failing to review multiple loops and

(2) failing to have a Board Certified Cardiologist

properly supervise and interpret the echocardiogram;

(3) failing

to examine the regurgitant jet throughout a portion of systole;
(4) over-manipulating echocardiogram settings;
Nyquist limit;

(5) setting a low

(6) characterizing "artifacts," "phantom jets,"

"backflow" and other low velocity flow as mitral regurgitation;
(7) failing to take a claimant's medical history; and
(8) overtracing the amount of a claimant's regurgitation.
PTO No. 2640 at 9-13, 15, 21-22, 26.

See

As previously noted,

Dr. Malki determined in audit that Dr. Concannon's finding of
moderate mitral regurgitation was based on overtracing the amount
of claimant's mitral regurgitation, and Dr. Vigilante determined
that the sonographer's measurements were inaccurate because they
included backflow and not mitral regurgitation.

Such

unacceptable practices cannot provide a reasonable medical basis
for the resulting diagnosis and Green Form answer of moderate
mitral regurgitation.
For the foregoing reasons, we conclude that claimant
has not met her burden of proving that there is a reasonable
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medical basis for finding that she had moderate mitral
regurgitation.

Therefore, we will affirm the Trust's denial of

the claim of Ms. Davis for Matrix Benefits.

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