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

Filing 5023

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9209 RE: CLAIMANT JANICE I. OAKS. SIGNED BY HONORABLE HARVEY BARTLE, III ON 3/20/2014; 3/20/2014 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110234 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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THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.

v.
AMERICAN HOME PRODUCTS
CORPORATION

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

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MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.

qL

March 10, 2014

Bartle, J.
Janice I. Oaks (a/k/a Janice I. Phillips)

("Ms. Oaks"

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.
In 2009, Pfizer, Inc. acquired Wyeth.
2. Jamie W. Oaks, claimant'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
(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 September, 2011, claimant submitted a completed
Green Form to the Trust signed by her attesting physician,
Roger W. Evans, M.D., F.A.C.P., F.A.C.C.

Based on an

echocardiogram dated May 21, 2009, 4 Dr. Evans attested in Part II
of claimant's Green Form that Ms. Oaks suffered from moderate
mitral regurgitation and a reduced ejection fraction in the range

3.
( ... continued)
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(l)-(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.
4.
Because claimant's May 21 2009 echocardiogram was performed
after the end of the Screening Period, claimant relied on an
echocardiogram dated June 27, 2002 to establish her eligibility
to receive Matrix Benefits.
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of 50% to 60%.

Based on such findings, claimant would be

entitled to Matrix A-1, Level II benefits in the amount of
$588,156. 5
In the report of claimant's May 21, 2009
echocardiogram, the reviewing cardiologist, Stacy D.
Brewington, M.D., stated that claimant's "ejection fraction [was]
greater than 60%."

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 March, 2012, the Trust forwarded the claim for

review by Rohit J. Parmar, M.D., F.A.C.C., one of its auditing
cardiologists.

In audit, Dr. Parmar concluded that there was no

reasonable medical basis for the attesting physician's finding of
a reduced ejection fraction.

Dr. Parmar explained:

In my review of the echocardiograms the
ejection fraction is over 60%.
In the
specific echocardiogram dated 5/21/09, the
ejection fraction is greater than 60%, in my
opinion. The echocardiogram report states
"the ejection fraction is greater than 60%."
I concur. 6
5. 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). 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.
6.

Dr. Parmar also found that there was no reasonable medical
(continued ... )
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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 ("Audit
Rules"), claimant contested this adverse determination. 7

In

contest, claimant submitted affidavits of Dr. Evans and Gregory
R. Boxberger, M.D., F.A.C.C.

In his affidavit, Dr. Evans stated,

in relevant part:
The Trust auditor found that the ejection
fraction shown in the subject echocardiogram
was greater than 60%.
I disagree with this
interpretation by the Trust auditor.
I
calculate the ejection fraction to be between
55% and 60%.
It is not greater than 60%.
In his affidavit, Dr. Boxberger stated, in relevant
part:
The Trust auditor found that the ejection
fraction in the subject echocardiogram was
greater than 60%.
I disagree with this
interpretation by the Trust auditor.
I
calculate the ejection fraction to be 58%
according to the Teichholz method.
It

6.
( ... continued)
basis for the attesting physician's finding that Ms. Oaks did not
have mitral annular calcification. Under the Settlement
Agreement, the presence of mitral annular calcification requires
the payment of reduced Matrix Benefits. See Settlement Agreement
§ IV.B.2.d. (2) (c)ii)d).
Given our disposition with respect to
claimant's ejection fraction, we need not address this issue.
7.
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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certainly is not greater than 60%. HY
opinion is consistent with the calculations
of the echocardiogram technologist who
performed the echocardiogram and calculated
the ejection fraction to be 58.5% according
to the Teichholz method.
(Emphasis in original.)
Claimant argued, therefore, that there was a reasonable
medical basis for her claim because these 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. Parmar submitted a declaration in which he again concluded
that there was no reasonable medical basis for the attesting
physician's finding that Ms. Oaks had a reduced ejection
fraction.

Dr. Parmar stated, in relevant part:
I confirm my finding at audit that there is
no reasonable medical basis for the Attesting
Physician's finding that Claimant had an
ejection fraction of 50-60%. At Contest, I
reviewed the May 21, 2009 Echocardiogram of
Attestation and confirmed that the ejection
fraction was greater than 60%. There is no
reasonable medical basis to conclude
otherwise.
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

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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 November 8, 2012, we

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

See PTO No. 8959

(Nov. 8, 2012).
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 February 14, 2013.

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, 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.

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
conflicting expert opinions exist, it is within the discretion of
the court to appoint a Technical Advisor to aid it in resolving
technical issues.
Id.
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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).

In support of her claim, Ms. Oaks repeats the arguments
she made in contest, namely, that the opinions of Dr. Evans and
Dr. Boxberger 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 that of the auditing cardiologist, Dr. Parmar.
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. Oaks contends

that if the Trust's auditing cardiologist or a Technical Advisor
concludes that an ejection fraction is as high as 79%, a finding

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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.

The Trust also contends that inter-reader

variability does not establish a reasonable medical basis for
this claim because Dr. Parmar specifically determined that there
was no reasonable medical basis for the attesting physician's
finding.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's May 21, 2009 echocardiogram and concluded that there
was no reasonable medical basis for the attesting physician's
finding that Ms. Oaks had a reduced ejection fraction.
Specifically, Dr. Vigilante determined, in pertinent part:
I determined the left ventricular end
diastolic and end systolic areas by
planimetering with electronic calipers in
both the apical four and two chamber views.
I determined the ejection fraction by
Simpson's Method. The left ventricular
ejection fraction was 69%.
This ejection
fraction never came close to approaching 60%.
This study was diagnostic of an ejection
fraction of greater than 60%. This finding
correlates with the finding of Dr. Brewington
who noted that the ejection fraction was
greater than 60% on the official
echocardiogram report.
I reviewed the
sonographer's calculation of the ejection
fraction of 58.5% via the Teichholz's Method.
This calculation, performed on the
parasternal long-axis view, was inaccurate as
the measurement was taken in an off-axis
rather than perpendicular line. The correct
ejection fraction was 69%.

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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.

Ms. Oaks does not rebut

Dr. Parmar's determination that, consistent with the
echocardiogram report for claimant's May 21, 2009 echocardiogram,
claimant's ejection fraction was greater than 60%. 9

Nor does

claimant challenge Dr. Vigilante's conclusion that claimant's
ejection fraction "never came close to approaching 60%" and that
the sonographer's calculation of claimant's ejection fraction,
noted by both Dr. Evans and Dr. Boxberger,

"was inaccurate as the

measurement was taken in an off-axis rather than perpendicular
line."

Neither claimant nor her experts identified any

particular error in the conclusions of the auditing cardiologist
and Technical Advisor. 10

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 . 11
Moreover, claimant's reliance on inter-reader
variability to establish a reasonable medical basis for the

9.
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.
10. Despite an opportunity to do so, claimant did not submit a
response to the Technical Advisor Report.
See Audit Rule 34.
11. Thus, we reject claimant's argument that the opinions of her
physicians provide a reasonable medical basis for her claim.
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attesting physician's representation that Ms. Oaks 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 claimant does not
adequately refute the auditing cardiologist's determination that
she had an ejection fraction greater than 60% and the Technical
Advisor concluded that claimant's ejection fraction was 69%.
Adopting claimant's argument that inter-reader variability
expands the range of a reduced ejection fraction by as much as
±19% would allow 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. 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 a reduced ejection
fraction.

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

of Ms. Oaks for Matrix Benefits and the related derivative claim
submitted by her spouse.

12. Moreover, the Technical Advisor specifically took into
account the concept of inter-reader variability as reflected in
his statement that, "An echocardiographer could not reasonably
conclude that an ejection fraction was in the range of 50-60%
when taking appropriate quantitative measurements even taking
into account the issue of inter-reader variability."
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