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

Filing 4479

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 8882 RE: CLAIMANT JANICE EAKLE. SIGNED BY HONORABLE HARVEY BARTLE, III ON 5/30/2012; 5/31/2012 ENTERED AND COPIES MAILED AND E-MAILED. (SEE PAPER # 109697 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:

v.

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AMERICAN HOME PRODUCTS
CORPORATION

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SHEILA BROWN, et al.

CIVIL ACTION NO. 99-20593

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2:16 MD 1203

MEMORANDUM IN SOPPORT OF SEPARATE PRETRIAL ORDER NO.

8882.

May 30, 2012

Bartle, J.

Janice Eakle ("Ms. Eakle" or "claimant"), a class
member under the Diet Drug Nationwide Class Action Settlement
Agreement ("Settlement Agreement") with Wyeth,l 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. Dennis L. Eakle, Ms. Eakle'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 (IIVHD"). 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
question~

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 August, 2002, claimant submitted a completed Green
Form to the

Trus~

signed by her attesting physician, Allan P.

Latcham, M.D., F.A.C.C.
litigation.

Dr. Latcham is no stranger to this

According to the Trust, he has signed at least 138

Green Forms on behalf of claimants seeking Matrix Benefits.
Based on an echocardiogram dated July 1, 2002, Dr. Latcham
attested in Part II of Ms. Eakle's Green Form that she suffered
from moderate mitral regurgitation, an abnormal left atrial

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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dimension, and a reduced ejection fraction in the range of 50% to
60%.4

Based on such findings, claimant would be entitled to

Matrix A-I, Level II benefits in the amount of $538,973. 5
In the report of claimant's echocardiogram, Dr. Latcham
noted that claimant had "moderate mitral valve regurgitation with
the mitral valve area to left atrial area ratio of 20.55%."
Under the definition set forth in the Settlement Agreement,
moderate or greater mitral regurgitation is present where the
regurgitant jet area (IIRJA") in any apical view is equal to or
greater than 20% of the left atrial area (IILAA").
Agreement

§

See Settlement

I.22.

In September, 2005, the Trust forwarded the claim for
review by Issam A. Mikati, M.D., one of its auditing
cardiologists. 6

In audit, Dr. Mikati determined that there was

no reasonable medical basis for the attesting physician's finding

4.
Dr. Latcham also attested that claimant suffered from New
York Heart Association Functional Class I symptoms. This
condition, however, is not at issue in this claim.

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
the 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 a
reduced ejection fraction, 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.
6.
Claimant incorrectly identifies the auditing cardiologist as
Rohit Parmer, M.D., who is an employee of Baylor University
Medical Center.
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that claimant had moderate mitral regurgitation because her
echocardiogram demonstrated only mild mitral regurgitation.

In

support of this conclusion, Dr. Mikati stated that claimant had
"[m]ild [regurgitation].
mitral regurgitant]

Backflow was traced to [inflate the

jet so that it reaches [moderate mitral

regurgitation] ."
Based on the auditing cardiologist's finding that
claimant had mild mitral regurgitation, the Trust issued a postaudit determination denying Ms. Eakle's claim.

Pursuant to the

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

In

contest, claimant argued that the auditing cardiologist's review
of the echocardiogram was flawed.

In support of this argument,

claimant submitted a letter from Waenard L. Miller, M.D.,
F.A.C.C.

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who stated that Ms. Eakle had "moderate mitral

regurgitation with RJA/LAA of 20%."

7. Claims placed into audit on or before December I, 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 I, 2002 are governed by the Audit Rules, as
approved in PTa No. 2807 (Mar. 26, 2003). There is no dispute
that the Audit Rules contained in PTa No. 2807 apply to
Ms. Eakle's claim.
8. Dr. Miller is also no stranger to this litigation. According
to the Trust, he has signed in excess of 2,872 Green Forms on
behalf of claimants seeking Matrix Benefits.
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The Trust then issued a final post-audit determination
again denying Ms. Eakle's claim.

Claimant disputed this final

determination and requested that the claim proceed to the show
cause process established in the Settlement Agreement.
Settlement Agreement

§

See

VI.E.7.; PTa No. 2807, Audit Rule 18{c).

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

On

June 12, 2006, we issued an Order to show cause and referred the
matter to the Special Master for further proceedings.

See PTO

No. 6372 (June 12, 2006).
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 August 31, 2006.

Under

the Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor 9 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, James F. Burke, M.D., F.A.C.C., to review the

9. 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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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
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).
The Technical Advisor, Dr. Burke, 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. Burke stated

that:
Upon my review of the tape, my overall
assessment of the mitral regurgitation is
mild.
Using representative beats in the apical four
chamber view, I calculated RJA/LAA
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(regurgitant jet area/left atrial area)
ratios to range from 5 to 10%. This
represents mild mitral regurgitation.
Using representative beats in the apical two
chamber view, I calculated RJA/LAA ratios to
range from 6 to 11%. This represents mild
mitral regurgitation.
Using representative beats in the apical
three chamber view, I calculated RJA/LAA
ratios to range from 4 to 7%. This
represents mild mitral regurgitation.
I agree with the assessment of Issam Mikati,
M.D. that the mitral regurgitant jet area was
traced in an inflated method that included
backflow.
In response to the Technical Advisor Report, claimant
argues that Dr. Burke failed to address Dr. Miller's
qualifications, and that Dr. Miller's findings should be given
deference based on his qualifications.

Claimant also notes that

Dr. Miller never met claimant and that there is "literally no
relationship between this doctor and the claimant .... "
After reviewing the entire Show Cause Record, we find
claimant's arguments are without merit.

First, claimant does not

refute the specific determinations of the Technical Advisor.

She

does not challenge Dr. Burke's conclusion that "even taking into
,account inter-reader variability, I believe there is no
reasonable medical basis for the [a]ttesting [p]hysician's answer
to Green Form Question C.3.a., which states that [c}laimant
suffers from moderate mitral regurgitation."

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On this basis

alone, claimant has failed to meet her burden of demonstrating
that there is a reasonable medical basis for her claim.
Moreover, we disagree with claimant that Dr. Miller's
letter establishes a reasonable medical basis for her claim.

As

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

(1) failing to review

(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;
echocardiogram settings;

(4) over-manipulating

(5) setting a low Nyquist limit;

(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.
22, 26 (Nov. 14, 2002).

See PTO No. 2640 at 9-13, 15, 21­

Here, both Dr. Mikati and Dr. Burke

found that claimant's attesting physician improperly
characterized backflow as mitral regurgitation.

Such an

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

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regurgitation.

Therefore, we will affirm the Trust's denial of

Ms. Eakle's claim for Matrix Benefits and the related derivative
claim submitted by her spouse.

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