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

Filing 4621

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 8983 RE: THE ESTATE OF GINGER S. GROGG, A.K.A. MARGUERITE G. GROGG. SIGNED BY HONORABLE HARVEY BARTLE, III ON 12/11/2012; 12/12/2012 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109841 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

N0.~'1~~

December 1/, 2012

Bartle, J.

The Estate of Ginger S. Grogg, a.k.a. Marguerite G.
Grogg ("Estate"), a representative claimant 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 the Estate has
demonstrated a reasonable medical basis to support its claim for
Matrix Compensation Benefits ("Matrix Benefits") . 3

1.
Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
2. Gregg S. Grogg, Gensa L. Baker, and Gaye Amaro, Ginger s.
Grogg's ("Ms. Grogg" or "decedent") children, have also submitted
derivative claims for benefits. The Trust, however, determined
that the derivative claimants are not eligible to receive
benefits.
3.

Matrix Benefits are paid according to two benefit matrices
(continued ... )

To seek Matrix Benefits, a representative claimant 4
must first submit a completed Green Form to the Trust.
Form consists of three parts.

The Green

The representative claimant

completes Part I of the Green Form.

Part II is completed by an

attesting physician who must answer a series of questions
concerning the decedent's medical conditions that correlate to
the Matrix criteria set forth in the Settlement Agreement.
Finally, if the representative claimant is represented by an
attorney, the attorney must complete Part III.
In November, 2003, Gregg S. Grogg, the legal
representative of the Estate of Ginger S. Grogg, submitted an
amended Green Form to the Trust signed by the attesting

3.
( ... continued)
(Matrix 11 A 11 and Matrix 11 B 11 ) , which generally classify for
compensation purposes Diet Drug Recipients 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 the Diet Drug Recipient's
valvular heart disease ( 11 VHD 11 ) .
See Settlement Agreement
§§ IV.B.2.b. & IV.B.2.d. (1)-(2).
Matrix A-1 describes the
compensation available to representative claimants where the Diet
Drug Recipients are diagnosed with serious VHD, they took the
drugs for 61 days or longer, and they 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
representative claimants where the Diet Drug Recipients were
registered as having only mild mitral regurgitation by the close
of the Screening Period, they took the drugs for 60 days or less,
or they were diagnosed with conditions that would make it
difficult for them to prove that their VHD was caused solely by
the use of these Diet Drugs.
4. Under the Settlement Agreement, representative claimants
include estates, administrators, or other legal representatives,
heirs or beneficiaries.
See Settlement Agreement § II.B.
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physician, Michael J. Liston, M.D. 5

Based on an echocardiogram

dated November 24, 1999, Dr. Liston attested in Part II of the
Green Form that Ms. Grogg suffered from moderate mitral
regurgitation6 and New York Heart Association Functional Class
III symptoms.

Dr. Liston further attested that Ms. Grogg had

surgery to repair or replace the aortic and/or mitral valve(s)
following the use of Pondimin® and/or Redux™ and an ejection
fraction of < 40% at any time six months or later after valvular
repair or replacement surgery.

Based on such findings,

the

Estate would be entitled to Matrix A-1, Level V benefits in the
amount of $479,876. 7
Dr. Liston also attested in the Green Form that the
Ms. Grogg did not suffer from mitral annular calcification.

5. The Estate also submitted a Green Form in December, 2004
signed by Jeffrey S. Fierstein, M.D.
The Trust contends this
Green Form is not operative because it was submitted after the
claim was complete and transferred to the Class Counsel Claims
Office pursuant to Pretrial Order ("PTO") No. 3882 (Aug. 26,
2004).
The Estate disagrees.
We, however, need not resolve this
dispute because the issue presented for our resolution is the
same under both Green Forms.
6.
Dr. Liston also attested that Ms. Grogg suffered from an
abnormal left atrial dimension and a reduced ejection fraction in
the range of 30% to 34%. These conditions are not at issue in
this claim.
7. Under the Settlement Agreement, a claimant or representative
claimant is entitled to Level V Matrix Benefits if the Diet Drug
Recipient qualifies for payment at Matrix Levels III or IV, had
New York Heart Association Functional Class III or Class IV
symptoms, underwent surgery to repair or replace the aortic
and/or mitral valve(s), and had a left ventricular ejection
fraction < 40% six months after valvular repair or replacement
surgery.
See Settlement Agreement§ IV.B.2.c. (5) (b)ii).
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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).

As the Trust

does not contest the Estate's entitlement to Level V benefits,
the only issue before us is whether the Estate is entitled to
payment on Matrix A-1 or Matrix B-1.
In March, 2005, the Trust forwarded the claim for
review by Donna R. Zwas, M.D., F.A.C.C., one of its auditing
cardiologists. 8

In audit, Dr. Zwas concluded that there was no

reasonable medical basis for Dr. Liston's finding that Ms. Grogg
did not have mitral annular calcification.

Specifically,

Dr. Zwas explained that "[p]osterior, lateral, and medial [mitral
annular calcification] is seen."
Based on the auditing cardiologist's finding that
Ms. Grogg had mitral annular calcification, the Trust issued a
post-audit determination that the Estate was entitled only to
Matrix B-1, Level V benefits.

Pursuant to the Rules for the

Audit of Matrix Compensation Claims ("Audit Rules"), the Estate
contested this adverse determination. 9

In contest, the Estate

8.
Pursuant to PTO No. 3882, all Level III, Level IV, and Level
V Matrix claims are subject to the Parallel Processing Procedures
("PPP"). As Wyeth did not agree that the Estate had a Matrix A,
Level V claim, pursuant to the PPP, the Trust audited the
Estate's claim.
9.
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 PTO
No. 2457 (May 31, 2002).
Claims placed into audit after
December 1, 2002 are governed by the Audit Rules, as approved in
(continued ... )
-4-

argued that the phrase "reasonable medical basis" means that an
attesting physician's conclusions must be accepted unless the
Trust proves they were "irrational, foolish,

senseless, etc. from

any medical perspective" and that a mere difference of opinion is
insufficient to deny a claim for Matrix Benefits (emphasis in
original) . 10

In addition, the Estate contended that there was a

reasonable medical basis for the attesting physician's
representation that Ms. Grogg did not suffer from mitral annular
calcification because seven additional physicians have examined
Ms. Grogg•s mitral valve, either directly or by echocardiogram,
and have not noted the presence of mitral annular
calcification. 11
Although not required to do so, in July, 2005, the
Trust forwarded the claim to the auditing cardiologist for a
second review.

Dr. Zwas submitted a declaration in which she

again concluded that there was no reasonable medical basis for

9.
( ... continued)
PTO No. 2807 (Mar. 26, 2003). There is no dispute that the Audit
Rules contained in PTO No. 2807 apply to the Estate's claim.
10. The Estate also argues, in this and later submissions, that
it should receive Matrix Benefits because the Trust did not
timely complete Ms. Grogg•s audit or otherwise comply with the
timing requirements of the Audit Rules.
The Estate, however,
failed to demonstrate how it was prejudiced by this delay. As we
previously discussed in PTO No. 6339, "we are unwilling to order
payment on an uncompensable claim solely based on an •out of
time• argument without, at a minimum, some showing of prejudice."
PTO No. 6339 at 13 n.10 (May 25, 2006).
11. The Estate subsequently submitted a letter to the Trust
arguing that the Trust subjected a prior Green Form to audit,
rather than the Green Form of Dr. Fierstein.
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the attesting physician's finding that Ms. Grogg did not have
mitral annular calcification.

In support of this conclusion,

Dr. Zwas stated:
I again observed unquestionable evidence of
mitral annular calcification on Ms. Grogg's
November 24, 1999 echocardiogram. Mitral
annular calcification is clearly observed in
the parasternal view at frame 00357.01
(9:15:44 on the clock), and in the apical
views at frame 00394.28 (09:00:45 on the
clock) .
Dr. Zwas also stated that whether the echocardiogram and cardiac
catheterization reports noted mitral annular calcification was
irrelevant to whether Ms. Grogg actually had mitral annular
calcification.

Finally, Dr. Zwas reviewed the January 18, 2000

angiogram and stated that it did not alter her conclusion.
Based on the second review, the Trust issued a final
post-audit determination, again determining that the Estate was
entitled only to Matrix B-1, Level V benefits.

The Estate

disputed this final determination, arguing that the Trust's
record was incomplete as it did not contain reports of
Ms. Grogg's December 1, 1994 and March 22, 1999 echocardiograms,
which it attached.

According to the Estate, the process was

"tainted" and it was entitled to a new audit.
In September, 2005, the Trust forwarded the claim to
Dr. Zwas for a third review.

Dr. Zwas submitted an amended

declaration in which she again concluded that Ms. Grogg had
mitral annular calcification and that there was no reasonable
medical basis for the attesting physician's representation to the

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contrary.

In addition, Dr. zwas stated that she considered the

two additional echocardiogram reports of December 1, 1994 and
March 22, 1999 and concluded that they were irrelevant to whether
Ms. Grogg's November 24, 1999 echocardiogram demonstrated mitral
annular calcification.

Dr. Zwas also explained that physicians

interpreting echocardiograms do not always comment on every
condition they observe, especially a common condition such as
mitral annular calcification.
Thus, in October, 2005, the Trust issued an amended
final post-audit determination, again determining that the Estate
was entitled only to Matrix B-1, Level V benefits.

The Estate

disputed this amended 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 Estate's claim
should be paid.

On January 12, 2006, we issued an Order to show

cause and referred the matter to the Special Master for further
proceedings.

See PTO No. 5940 (Jan. 12, 2006).

Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
documentation.
Special Master.

The Estate then served a response upon the
The Trust submitted a reply on June 23, 2006,

and the Estate submitted a sur-reply on August 10, 2006.

Under

the Audit Rules, it is within the Special Master's discretion to

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appoint a Technical Advisor 12 to review claims after the Trust
and the Estate 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 the Estate 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 the Estate has met its burden in proving that there is a
reasonable medical basis for the attesting physician's finding
that Ms. Grogg did not have mitral annular calcification.
id. Rule 24.

See

Ultimately, if we determine that there is no

reasonable medical basis for the answer in the 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).

12. 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.
-8-

In support of its claim, the Estate reasserts the
arguments it made in contest; namely, that none of the physicians
involved in Ms. Grogg's care noted that the she had mitral
annular calcification.

The Estate also objects to the fact that

its claim was "audited" three times.
In response, the Trust argues that the medical records
cited by the Estate do not establish a reasonable medical basis
for the Green Form representation that Ms. Grogg did not have
mitral annular calcification.

According to the Trust, the issue

is whether Ms. Grogg's November 22, 1999 echocardiogram, not
other echocardiograms, demonstrates mitral annular calcification.
In addition, the Trust contends that the "failure to note the
presence of mitral annular calcification in an echocardiogram
report does not negate its existence."

The Trust also asserts

that a surgeon would not be in a position to view mitral annular
calcification and that the pathologist only was given a portion
of the mitral valve and not the annulus.
The Technical Advisor, Dr. Vigilante, reviewed
Ms. Grogg's echocardiogram and medical records and concluded that
there was no reasonable medical basis for the attesting
physician's finding that Ms. Grogg did not have mitral annular
calcification.

Specifically, Dr. Vigilante found that:

This study demonstrated obvious significant
mitral annular calcification. There was
rather severe thickening of the
posterolateral annulus with increased
reflectance of echoes consistent with
calcification. This was a definite diagnosis
on this study. This is not even close to a
-9-

borderline call.
The calcification also
involved part of the mitral leaflets and
subvalvular apparatus including chords.
This
calcification was also seen medially along
the mitral annulus. The mitral annular
calcification was noted in the parasternal
long-axis view, parasternal short-axis view,
apical four chamber view, apical two chamber
view, and subcostal view....
The time frames
documented by Dr. Zwas on the tape were
reviewed in detail and, indeed, demonstrated
obvious mitral annular calcification.
In response to the Technical Advisor Report, the Estate
argues that Dr. Vigilante "is obviously a pawn of the Trust
placed in a position to ensure that Claimants are summarily
denied benefits that they are rightfully entitled to .... "

The

Estate also asserts that the opinions of Dr. Zwas and
Dr. Vigilante are entitled to less weight than the opinions
provided by Ms. Grogg's physicians because Dr. Zwas and
Dr. Vigilante are not "clinical cardiologists" and many of the
opinions provided by Ms. Grogg's physicians were not related to
or dictated by litigation.
After reviewing the entire Show Cause Record, we find
the Estate's arguments are without merit.

As an initial matter,

the Estate does not adequately refute or respond to the findings
of Dr. Zwas or Dr. Vigilante.

Specifically, Dr. Zwas determined

that the November 24, 1999 echocardiogram demonstrated mitral
annular calcification "in the parasternal view at frame 00357.01
(9:15:44 on the clock), and in the apical views at frame 00394.28

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( 09:00:45 on the clock) . 1113

Dr. Vigilante reviewed these frames

and confirmed that they "demonstrated obvious mitral annular
calcification.

1114

Rather than challenge these specific findings,

the Estate relies on various echocardiogram and cardiac
catheterization reports, an operative report, and a pathology
report, each of which is silent on the presence of mitral annular
calcification.

Dr. Zwas, however, specifically noted that a

cardiologist interpreting an echocardiogram will not always
reference every condition observed, particularly when the
condition is a common one like mitral annular calcification.

In

addition, the Trust contended that the surgeon who completed the
surgical report noted that visibility of the mitral valve during
surgery "was very poor" and that only a portion of the mitral
valve, not the mitral annulus, was provided to the pathologist.
The Estate did not address these contentions or identify any
particular error in the conclusions of the auditing cardiologist
or the Technical Advisor.

Mere disagreement with the auditing

cardiologist and the Technical Advisor without identifying any
13. We also reject the Estate's contention that the claim should
be paid because it was subjected to audit three times by the same
auditing cardiologist. The Trust submitted the claim for second
and third reviews based on arguments and information submitted by
the Estate subsequent to the audit that Dr. Zwas had purportedly
had not considered. We perceive nothing improper with this
practice, and the Estate has not demonstrated how it was
prejudiced by the second and third reviews of Dr. Zwas.
14. The Estate's arguments that Dr. Vigilante is biased or
unqualified are also without merit. We appointed Dr. Vigilante,
after determining that he possessed the necessary skills and
expertise, to assist us in reviewing Matrix claims in the show
cause process.
See PTO No. 3212 at 9 (Jan. 14, 2004).
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specific errors by them is insufficient to meet a the Estate's
burden of proof.
We also disagree with the Estate's definition of
reasonable medical basis.

Without any discussion, the Estate

relies on Gallagher v. Latrobe Brewing Co., 31 F.R.D. 36
(W.D. Pa. 1962) and Black's Law Dictionary, 1538 (6th ed. 1990),
for determining what constitutes a reasonable medical basis.
Such reliance, however, is misplaced.

In Gallagher, the court

simply addressed the circumstances under which the court would
appoint an impartial expert witness to be presented to the jury
and, therefore, the case is not apposite.
F.R.D. at 38.

See Gallagher, 31

The Estate also relies on the definition of

"unreasonable" in Black's.
"not guided by reason."

One of the definitions, however, is

The word "unreasonable" does not always

mean "irrational" as the Estate would have us believe and it does
not mean that here.

We are not persuaded that either Gallagher

or Black's supports the Estate's position.
For the foregoing reasons, we conclude that the Estate
has not met its burden of proving that there is a reasonable
medical basis for finding that Ms. Grogg did not have mitral
annular calcification.

Therefore, we will affirm the Trust's

denial of the Estate's claim for Matrix A benefits.

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