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

Filing 4573

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 8956 RE: CLAIMANT DEBORAH ESTES. SIGNED BY HONORABLE HARVEY BARTLE, III ON 11/6/2012; 11/7/2012 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109796 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

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MDL NO. 1203

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v.

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AMERICAN HOME PRODUCTS
CORPORATION,

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THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.,

CIVIL ACTION NO. 99-20593

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2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

Bartle, J.

8'15(o

November

b , 2012

Deborah Estes ("Ms. Estes" or "claimant"}, a class
member under the Diet Drug Nationwide Class Action Settlement
Agreement ("Settlement Agreement"} with Wyeth,
from the AHP Settlement Trust ("Trust"} . 2

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"} . 3
1.
Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
2.
Robert M. Estes and Bonnie M. Estes, claimant's children,
also have submitted derivative claims 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 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 physician, Gregory R.
Boxberger, M.D., F.A.C.C.

Based on an echocardiogram dated

September 24, 2001, Dr. Boxberger attested in Part II of
claimant's Green Form that Ms. Estes suffered from moderate
mitral regurgitation, an abnormal left atrial dimension, an
abnormal left ventricular end-systolic dimension, and a reduced
ejection fraction of less than 30%.

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 $545,310. 4
In the report of claimant's echocardiogram, the
reviewing cardiologist, Lynda 0. Tirao, M.D., stated that
claimant had mild mitral regurgitation.

Dr. Tirao, however, did

not specify a percentage as to claimant's level of mitral
regurgitation. 5

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").
See Settlement Agreement

§

I.22.

In September, 2003, the Trust forwarded the claim for
review by Robert L. Gillespie, M.D., F.A.S.E., F.A.C.C., one of
its auditing cardiologists.

In audit, Dr. Gillespie concluded

that there was no reasonable medical basis for the attesting
physician's finding that Ms. Estes had moderate mitral

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). As the Trust does
not contest the attesting physician's findings of an abnormal
left atrial dimension or a reduced ejection fraction, each of
which is one of the complicating factors needed to qualify for a
Level II claim, the only issue is claimant's level of mitral
regurgitation.
5.
Claimant also submitted an echocardiogram report prepared by
Dr. Boxberger in July, 2002 based on her September 24, 2001
echocardiogram.
In this report, Dr. Boxberger stated that
claimant had "moderate mitral regurgitation, based on RJA to LAA
radio [sic] of .2."
-3-

regurgitation because her echocardiogram demonstrated only mild
mitral regurgitation.

In support of this conclusion,

Dr. Gillespie explained that the "RJA/LAA was not 20% or greater
in any of the views evaluated.

The parasternal jet was less than

10% and the apicals less than 15%."
Based on the auditing cardiologist's finding that
claimant had mild mitral regurgitation, the Trust issued a
post-audit determination denying the claim.

Pursuant to the

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

In

contest, claimant submitted affidavits from Dr. Boxberger, Roger
W. Evans, M.D., F.A.C.P., F.A.C.C.,
F.A.C.P., F.A.C.C.

7

and G. Whitney Reader, M.D.,

In his affidavit, Dr. Boxberger confirmed his

previous finding that claimant had moderate mitral regurgitation
with an RJA/LAA of 20%.

Dr. Evans stated that "[t]he

echocardiogram tape in question shows 'moderate' mitral valve
regurgitation with an RJA/LAA ratio of 22%."

Dr. Reader also

concluded that claimant's echocardiogram showed moderate mitral

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 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.

Dr. Evans is no stranger to this litigation. According to
the Trust, he has signed in excess of 322 Green Forms on behalf
of claimants seeking Matrix Benefits.
See PTO No. 8412
(Mar . 9 , 2 0 1 o) .
7.

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regurgitation, and found "an RJA/LAA ratio of at least 20%."
Claimant argued, therefore, that she had established a reasonable
medical basis for her claim because three Board-Certified
Cardiologists independently agreed that she had moderate mitral
regurgitation.

Claimant further asserted that the auditing

cardiologist "apparently did not understand the difference
between his personal opinion
basis' standard."

and the 'reasonable medical

(Emphasis in original.)

Although not required to do so, the Trust forwarded the
claim to the auditing cardiologist for a second review.
Dr. Gillespie submitted a declaration in which he again concluded
that there was no reasonable medical basis for the attesting
physician's finding that Ms. Estes had moderate mitral
regurgitation.

Specifically, Dr. Gillespie stated:

In connection with my review, I found that
Claimant's echocardiogram tape is of such
poor quality that it was not possible to
planimeter the tape.
It is clear from a
visual observation of the tape, however, that
Claimant's [RJA/LAA] ratio is 10% - 15%, and
clearly no more than 15%. Moreover, I
observed that the echocardiogram report
prepared in connection with the
echocardiogram that is the basis of
Claimant's claim indicates that Claimant has
only mild mitral regurgitation.
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).

-5-

The Trust then applied to the court for issuance of an Order to
show cause why the claim should be paid.

On March 26, 2004, we

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

See PTO No. 3380

{Mar . 2 6 , 2 oo4 ) .
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 November 3, 2004, and

claimant submitted a sur-reply on November 19, 2004.

Under the

Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor 8 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, Sandra V. Abramson, 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.

8. 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.
-6-

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
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, Ms. Estes 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 moderate mitral regurgitation.
Claimant also 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. Gillespie.

According to claimant, there is an "absolute"

inter-reader variability of 15% when evaluating mitral
regurgitation.

Thus, Ms. Estes contends that if the Trust's

auditing cardiologist or a Technical Advisor concludes that the
RJA/LAA ratio for a claimant is 5%, a finding of a 20% RJA/LAA
ratio by an attesting physician is medically reasonable.

-7-

In response, the Trust argues that the opinions of
Dr. Evans and Dr. Reader do not establish a reasonable medical
basis for the claim of Ms. Estes because they are all based on
the "same erroneous interpretation of [claimant's] echocardiogram
as Dr. Boxberger's finding and are in direct conflict with the
findings of the report prepared contemporaneously with
[claimant's] echocardiogram."

The Trust also contends that

inter-reader variability does not establish a reasonable medical
basis for the claim because Dr. Gillespie specifically determined
that there was no reasonable medical basis for Dr. Boxberger's
findings.

9

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

Specifically,

Dr. Abramson found:
In reviewing the transthoracic
echocardiogram, my visual estimate is that
there is only mild mitral regurgitation.
I
chose not to measure this jet because it is
not even close to being moderate.
The
quality of this echocardiogram is fair, but
it is clear that there is only mild mitral
regurgitation.
There is merely a central jet
which is only seen in the apical-4-chamber

9.
The Trust also argues that claimant's additional expert
reports should be disregarded because Ms. Estes did not disclose
their compensation or submit a list of previous cases in which
they have served. 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.lO (Feb. 26, 2007).
-8-

view.
The [claimant] is tachycardic which
causes artifact that may have been misread as
mitral regurgitation.
The color gains are
also inappropriately increased which may also
account for color flashing which may have
been misread as mitral regurgitation.
After reviewing the entire show cause record, we find
claimant's arguments are without merit.

First, claimant does not

adequately refute the findings of the auditing cardiologist or
the Technical Advisor.

She does not rebut the auditing

cardiologist's determination that the "RJA/LAA was not 20% or
greater in any of the views evaluated. " 10

Nor does she challenge

Dr. Abramson's conclusion that "there is only mild mitral
regurgitation.

There is merely a central jet which is only seen

in the apical-4-chamber view." 11

Although Ms. Estes submitted

the affidavits of several cardiologists, neither claimant nor her
experts identified any particular errors in the conclusions of
the auditing cardiologist or the Technical Advisor.

They also

did not provide an explanation for the reviewing cardiologist's
determination that claimant's echocardiogram demonstrated only
mild mitral regurgitation.

Mere disagreement with the auditing

cardiologist or the Technical Advisor without identifying any
specific error by them is insufficient to meet a claimant's
burden of proof.

10.
For this reason as well, we reject claimant's argument that
the auditing cardiologist substituted his personal opinion for
the diagnosis of the attesting physician.
11. Despite an opportunity to do so, claimant did not submit a
response to the Technical Advisor Report.
See Audit Rule 34.
-9-

Moreover, we disagree with claimant that the opinions
of her physicians establish a reasonable medical basis for her
claim.

We are required to apply the standards delineated in the

Settlement Agreement and Audit Rules.

The context of those 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 (Nov. 14, 2002).

See

Here,

Dr. Abramson determined that claimant was tachycardic and that
the color gain settings were inappropriately increased, resulting
in, respectively, artifact and color flashing, which may have
been misread by claimant's attesting physician and expert
cardiologists as mitral regurgitation.

Such an unacceptable

practice cannot provide a reasonable medical basis for the
resulting diagnosis and Green Form representation that claimant
suffered from moderate mitral regurgitation.
-10-

Finally, claimant's reliance on inter-reader
variability to establish a reasonable medical basis for the
attesting physician's representation that Ms. Estes had moderate
mitral regurgitation is misplaced.

The concept of inter-reader

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

In this instance, the attesting physician's opinion

cannot be reasonable where the Technical Advisor concluded that
claimant had only mild mitral regurgitation and the auditing
cardiologist determined that claimant's echocardiogram
demonstrated RJA/LAA ratios of less than 15% in the apical views
and 10% in the parasternal views.

Adopting claimant's argument

that inter-reader variability would expand the range of moderate
mitral regurgitation by ±15% would allow a claimant to recover
benefits with an RJA/LAA as low as 5%.

This result would render

meaningless this critical provision of the Settlement
Agreement . 12
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 moderate mitral
regurgitation.

Therefore, we will affirm the Trust's denial of

12. Moreover, the Technical Advisor took into account the
concept of inter-reader variability as reflected in her statement
that "it would be impossible for a reasonable echocardiographer
to interpret this severity of mitral regurgitation as moderate.
There is no reasonable medical basis for the Attesting
Physician's claim that this Claimant has moderate mitral
regurgitation, even taking into account inter-reader
variability."
-11-

the claim of Ms. Estes for Matrix Benefits and the related
derivative claims submitted by her children.

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