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

Filing 4765

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9063 RE: CLAIMANT JANICE PHILLIPS. SIGNED BY HONORABLE HARVEY BARTLE, III ON 5/10/2013; 5/10/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109978 IN 11-MD-1203). (tjd) (Main Document 4765 replaced on 5/10/2013) (tjd, ).

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: DIET DRUGS (PHENTERMINE/
FENFLURAMINE/DEXFENFLURAMINE)
PRODUCTS LIABILITY LITIGATION

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THIS DOCUMENT RELATES TO:

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MDL NO. 1203

__________________________________ )
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SHEILA BROWN, et al.

v.
AMERICAN HOME PRODUCTS
CORPORATION

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CIVIL ACTION NO. 99-20593

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2:16 MD 1203

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MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

q0 G, 3

May I 0, 2013

Bartle, J.

Janice Phillips ("Ms. Phillips" 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.
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 July, 2002, claimant submitted a completed Green
Form to the Trust signed by her attesting cardiologist, Gregory
R. Boxberger, M.D., F.A.C.C.

Based on an echocardiogram dated

June 27, 2002, Dr. Boxberger attested in Part II of claimant's
Green Form that Ms. Phillips suffered from moderate mitral
regurgitation and a reduced ejection fraction in the range of SO%
to 60%.

Based on such findings, claimant would be entitled to

Matrix A-1, Level II benefits in the amount of $518,044. 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. Boxberger stated that claimant had a

11

[n]ormal left

ventricular size, with systolic performance estimated in the
range of 55%.

11

An ejection fraction is considered reduced for

purposes of a mitral valve claim if it is measured as less than
or equal to 60%.

See Settlement Agreement

§

IV.B.2.c. (2) (b)iv).

In September, 2003, the Trust forwarded the claim for
review by James W. Mathewson, M.D., one of its auditing
cardiologists.

In audit, Dr. Mathewson concluded that there was

no reasonable medical basis for Dr. Boxberger's finding of a
reduced ejection fraction in the range of 50% to 60%.
Dr. Mathewson explained:
The qualitative and quantitative measures of
left ventricular ejection fraction are
normal. My measurements of LVIDd and LVIDs
are 46 and 29mm respectively. The LV apex
moves normally in systole. The estimated
ejection fraction with these numbers is about
70%. The LV shortening fracitgon [sic] is
37% consistant [sic] with this finding.
Based on the auditing cardiologist's finding that claimant
did not have a reduced ejection fraction, the Trust issued a
post-audit determination denying the claim.

Pursuant to the

Rules for the Audit of Matrix Compensation Claims ( 11 Audit

3.
( ... continued)
the five complicating factors delineated in the Settlement
Agreement. See Settlement Agreement § IV.B.2.c. (2) (b). A
reduced ejection fraction is one of the complicating factors
needed to qualify for a Level II claim. Although the Trust
contests claimant's level of mitral regurgitation, we need not
resolve this dispute given our determination as to claimant's
ejection fraction.
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Rules"), claimant contested this adverse determination. 4

In

contest, claimant submitted affidavits of Dr. Boxberger, Robert
W. Evans, M.D., F.A.C.P., F.A.C.C., and G. Whitney Reader, M.D.,
F.A.C.P., F.A.C.C.

Each of these physicians recognized that

claimant's ejection fraction was more than 60%, but concluded
that it was reasonable for the attesting physician to state that
claimant had a reduced ejection fraction in the range of 50% to
60%.

Claimant argued, therefore, that there was a reasonable

medical basis for her claim because three Board Certified
cardiologists independently agreed that she had a reduced
ejection fraction.

Claimant further asserted that the auditing

cardiologist "apparently did not understand the difference
between his personal opinion

and the 'reasonable medical

basis' standard."
Although not required to do so, the Trust forwarded the
claim to the auditing cardiologist for a second review.
Dr. Mathewson submitted a declaration in which he again concluded
that there was no reasonable medical basis for the attesting
physician's finding that Ms. Phillips had a reduced ejection
fraction.

In support of this conclusion, Dr. Mathewson stated:

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.
-4-

Upon review I also affirmed my findings that
the qualitative and quantitative measures of
Claimant's left ventricular ejection fraction
are normal. Visually, the ejection fraction
is greater than 60%. The left ventricular
apex is moving normally in systole. My
measurements of LVIDd and LVIDs (at 46 and 29
mm, respectively) confirm that Claimant's
ejection fraction is approximately 70% and
the left ventricular shortening fraction is
37%. There is no reasonable medical basis
for a finding of a reduced ejection fraction
less than or equal to 60%.
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 the claim should be paid.

On May 3, 2004 we

issued an Order to show cause and referred the matter to the
Special Master for further proceedings. See PTO No. 3492
(May 3, 2004).
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 8, 2004, and

claimant submitted a sur-reply on October 22, 2004.

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

5.

A "[Technical]

[A]dvisor's role is to act as a sounding board
(continued ... )
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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 of proving that there is a
reasonable medical basis for the attesting physician's finding
that she suffered from a reduced ejection fraction.
Rule 24.

See id.

Ultimately, if we determine that there is 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.
Rule 38(a).

See id.

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).

5.
( ... continued)
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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In support of her claim, Ms. Phillips repeats the
arguments she made in contest, namely, that the opinions of
Dr. Boxberger, Dr. Evans, and Dr. Reader provide a reasonable
medical basis for the finding of a reduced ejection fraction.

In

addition, claimant contends that the concept of inter-reader
variability accounts for the differences between the opinions
provided by claimant's physicians and the auditing cardiologist,
Dr. Mathewson.

According to claimant, there is an "absolute"

inter-reader variability of 18% when evaluating an ejection
fraction using Simpson's Rule, 16% when using the wall motion
index, and 19% when using subjective visual assessment.

Thus,

Ms. Phillips contends that if the Trust's auditing cardiologist
or a Technical Advisor concludes that an ejection fraction is as
high as 79%, a finding of an ejection fraction of 60% by an
attesting physician is medically reasonable.
In response, the Trust argues that the opinions of
claimant's physicians do not establish a reasonable medical basis
for her claim because they concede that claimant's ejection
fraction was greater than 60% and fail to explain why it would be
reasonable to say that her ejection fraction was in the range of
50% to 60%.

The Trust also contends that inter-reader

variability does not establish a reasonable medical basis for
this claim because Dr. Mathewson specifically determined that

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there was no reasonable medical basis for the attesting
physician's finding.

6

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 Ms. Phillips had a reduced ejection fraction.

Specifically,

Dr. Vigilante determined,
The left ventricle was normal in size and
completely normal in contractility.
In fact,
there was hyperdynamic contractility
particularly noted in the apical two chamber
view at 10:04:45 on the tape. The ejection
fraction was greater than 70%.
After reviewing the entire Show Cause Record, we find
claimant's arguments are without merit.

As an initial matter,

claimant does not adequately refute the findings of the auditing
cardiologist or the Technical Advisor.

Claimant does not rebut

Dr. Mathewson's determination that his "measurements of
[claimant's] LVIDd and LVIDs (at 46 and 29 mm, respectively)

6. The Trust also argues that Audit Rule 18(b) prohibits the
submission of more than one expert report. We disagree. We
previously have declined to impose a limitation on the number of
verified expert opinions that may be submitted by a claimant.
See, e.g., PTO No. 7111 at 6 n.9 (Apr. 12, 2007).
In addition,
the Trust argues that claimant's additional expert reports should
be disregarded because Ms. Phillips did not disclose their
compensation or submit a list of previous cases in which they
have served. Again, we disagree. As we previously have held,
requiring disclosures pursuant to Rule 26(a) (2) of the Federal
Rules of Civil Procedure would serve no purpose given the
prohibition on discovery contained in the Audit Rules. See,
~, PTO No. 6996 at 7 n.10 (Feb. 26, 2007).
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confirm that Claimant's ejection fraction is approximately 70%.

117

Nor does claimant challenge Dr. Vigilante's conclusion that
n

[t]he left ventricle was normal in size," "completely normal in

contractility," and "greater than 70%.

118

Neither claimant nor

her experts identified any particular error in the conclusions of
the auditing cardiologist and Technical Advisor.

Mere

disagreement with the auditing cardiologist and Technical Advisor
without identifying any specific errors by them is insufficient
to meet a claimant's burden of proof.
Moreover, claimant's reliance on inter-reader
variability to establish a reasonable medical basis for the
attesting physician's representation that Ms. Phillips had a
reduced ejection fraction is misplaced.

The concept of

inter-reader variability is already encompassed in the reasonable
medical basis standard applicable to claims under the Settlement
Agreement.

In this instance, the attesting physician's opinion

cannot be medically reasonable where the auditing cardiologist
determined that claimant had an ejection fraction of "about 70%"
and the Technical Advisor concluded that claimant's ejection
fraction was "greater than 70%.

11

Adopting claimant's argument

that inter-reader variability would expand the range of a reduced
ejection fraction by as much as ±19% would allow, as noted above,

7.
For this reason as well, we reject claimant's argument that
the auditing cardiologist simply substituted his personal opinion
for the diagnosis of the attesting physician.
8. Despite an opportunity to do so, claimant did not submit a
response to the Technical Advisor Report. See Audit Rule 34.
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a claimant to recover benefits with an ejection fraction as high
as 79%.

This result would render meaningless this critical

provision of the Settlement Agreement. 9
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 had a reduced ejection
fraction.

Therefore, we affirm the Trust•s denial of the claim

of Ms. Phillips for Matrix Benefits.

9. Moreover, the Technical Advisor specifically took into
account the concept of inter-reader variability as reflected in
his statement that, 11 Even taking into consideration the issue of
inter-reader variability, it would be impossible for a reasonable
echocardiographer to conclude that the Claimant•s ejection
fraction was in the range of 50% - 60%. 11
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