BROWN, et al v. AMERICAN HOME PROD, et al
Filing
4870
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9129 RE: LORRAINE HART. SIGNED BY HONORABLE HARVEY BARTLE, III ON 8/13/2013; 8/13/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110087 IN 11-MD-1203). (tjd)
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IN THE UNITED STATES DI~TRICT 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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CIVIL ACTION NO. 99-20593
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THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.
v.
AMERICAN HOME PRODUCTS
CORPORATION
2:16 MD 1203
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.
q 12. q
August J3, 2013
Bartle, J.
Lorraine Hart ("Ms. Hart" 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
Ms. Hart has demonstrated a reasonable medical basis to support
her claim for Matrix Compensation Benefits ("Matrix Benefits")
and, if so, whether she met her burden of proving that her claim
was not based, in whole or in part, on any intentional material
misrepresentation of fact.
2
1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
In 2009, Pfizer Inc. acquired Wyeth.
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
(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 completes Part III if
claimant is represented.
In December, 2002, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, W. Marcus
Brann, M.D., F.A.C.C., F.A.C.P.
litigation.
Dr. Brann is no stranger to this
According to the Trust, he has signed in excess of
764 Green Forms on behalf of claimants seeking Matrix Benefits.
Based on an echocardiogram dated October 22, 2002, Dr. Brann
attested in Part II of claimant's Green Form that Ms. Hart
suffered from moderate mitral regurgitation and an abnormal left
2.
( ... continued)
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
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.
-2-
atrial dimension. 3
Based on such findipgs, claimant would be
entitled to Matrix A-1, Level II benefits in the amount of
$496,153. 4
In the report of claimant's echocardiogram, Dr. Brann
stated that Ms. Hart had moderate mitral regurgitation of 24%.
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").
Agreement
§
I.22.
See Settlement
Dr. Brann also stated that "[t]here is mild
left atrial enlargement" and noted that the left atrium measured
56 mm in the supero-inferior dimension and 44 mm in the
antero-posterior dimension.
The Settlement Agreement defines an
abnormal left atrial dimension as a left atrial supero-inferior
systolic dimension greater than 5.3 em in the apical four chamber
view or a left atrial antero-posterior systolic dimension greater
than 4.0 em in the parasternal long axis view.
§
See id.
IV . B . 2 . c . ( 2 ) (b) i i ) .
3. Dr. Brann also attested that claimant suffered from New York
Heart Association Functional Class III symptoms. This condition
is not at issue in this claim.
4. Under the Settlement Agreement, an eligible class member 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).
An abnormal left atrial dimension is one of
the complicating factors needed for a Level II claim.
-3-
In December, 2005, the Trust forwarded the claim for
review by Issam A. Mikati, M.D., F.A.c.jc., F.A.H.A., F.A.S.E.,
one of its auditing cardiologists. 5
i
I
Inl aud1t, Dr. Mikati
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concluded that there was a reasonable medical basis for
Dr. Brann's findings that claimant had moderate mitral
regurgitation and an abnormal left atrial dimension.
Pursuant to Rule 5 of the Rules for the Audit of Matrix
Compensation Claims ("Audit Rules"), the Trust undertook "to
determine whether there were any intentional material
misrepresentations made in connection with the Claim."
As part
of this review, the Trust engaged Joseph Kisslo, M.D., to review
the integrity of echocardiogram system use during the performance
of echocardiographic studies and the resulting interpretations
submitted in support of certain claims.
As stated in his
September 19, 2006 declaration, Dr. Kisslo determined, in
pertinent part, that:
In Ms. Hart's study, the use of high color
gain, high image gain, color persistence,
decreased low velocity reject, and color
pixels dominant over anatomy, the selection
and planimetry of backflow, and the
overmeasurement of the mitral "jet," as well
5. The Trust originally forwarded the claim for review by one of
its auditing cardiologists in or around March, 2004, who accepted
Dr. Brann's findings of moderate mitral regurgitation and an
abnormal left atrial dimension. The Trust, however, never issued
a determination based on this review because we subsequently
imposed a stay on the processing of claims pending implementation
of the Seventh Amendment to the Settlement Agreement. After the
stay was lifted, we entered Pretrial otder ("PTO") No. 5632,
which allowed the Trust to re-audit Matrix claims that were
reviewed by auditing cardiologists but for which the Trust had
not issued post-audit determinations. The Matrix claims that
were subject tore-audit included Ms. Hart's claim.
-4-
as the undermeasurement of t~e left atrial
area are the result of deliberate choices and
conduct engaged in by the so~ographer
performing this study and at:a minimum,
acquiesced in by the Attesti~g Physician.
Each of these manipulations exaggerated or
created the appearance of regurgitation or
jet duration.
Thus, notwithstanding Dr. Mikati's findings at audit,
the Trust issued a post-audit determination denying Ms. Hart's
claim based on its conclusion that there was substantial evidence
of intentional material
with the claim.
misrepresentat~on
of fact in connection
Pursuant to the Audit.Rules, Ms. Hart contested
this adverse determination. 6
In contest, claimant noted that she
did not dispute the findings of the two auditing cardiologists
who determined there was a reasonable medical basis for her
claim.
Instead, she submitted a letter from Robert E. Fowles,
M.D., dated November 21, 2006, wherein he stated that he reviewed
claimant's October 22, 2002 echocardiogram and measured the
mitral regurgitant jet area to be 23%.
Dr. Fowles specifically
noted that he took into account Dr. Kisslo's observations and
objections but noted that "in the frames I used for
determination, I do not find excessive color gain, persistence,
tissue encroachment
[or] detect axial or lateral smoothing."
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
Ms. Hart's claim.
-5-
In addition, Ms. Hart included with her contest a September 8,
1
i
2005 letter from Class Counsel to the
T~ust
7
and a motion filed
!
on behalf of Ms. Hart and several other claimants represented by
Ms. Hart's law firm to enforce PTO No. 5632 or to set aside PTO
No. 5632 and to compel production of ce,rtain Trust documents. 8
The Trust then issued a final post-audit determination,
again denying Ms. Hart's claim.
The Trust asserted that
Dr. Fowles did not respond to most of the Trust's evidence of
intentional material misrepresentations of fact.
Specifically,
the Trust noted that Dr. Fowles did not respond to Dr. Kisslo's
findings that the echocardiographer who performed Ms. Hart's
October 22, 2002 echocardiogram "used high color gain, imagine
gain, color persistence, color pixel dominance and improperly
measured backflow instead of sustained high velocity flow,
overtraced the jet beyond its borders and undertraced the left
atrial area."
The Trust further asserted that in instances where
Dr. Fowles did disagree with Dr. Kisslo, he failed to "identify
7.
In this letter, Class Counsel argued, among other things,
that the Trust could not deny payment on any claim in which a
post-audit determination letter had been sent unless it found
that the claim was based on a fraudulent echocardiogram and that
the Trust could not rely on the reports of Dr. Kisslo to
determine whether a claim in which a post-audit determination
letter had been sent was fraudulent.
The issues raised in Class
Counsel's letter also were the subject of a motion filed by Class
Counsel and joined by a number of firms representing various
Class Members.
Class Counsel and all but one firm subsequently
withdrew the motion after the adoption of certain Court Approved
Procedures. We denied the motion of the remaining firm following
briefing and argument. See PTO No. 6099 (Mar. 31, 2006).
8. We subsequently denied this motion.
No. 9114, at 6 n.8 (July 23, 2013).
-6-
See Mem. in Supp. of PTO
------------,------------------------
the frames upon which he relied in mak1ng those determinations or
in reaching his conclusion that [Ms. Hart had] moderate mitral
regurgitation.
11
Moreover, the Trust noted that, notwithstanding
their differing opinions, Dr. Fowles concluded that
11
Dr. Kisslo's
project is a detailed and painstaking exploration and dissection
of ultrasound imaging as applied to the particular issues at
hand,
11
which included
11
an exhaustive systematic analysis of
echocardiographic technique and result$ as portrayed by the
commercial imaging company,
'Sound Sou:tce. '
I
11
The Trust also
contended that Class Counsel's letter could not support
Ms. Hart's claim for benefits because it did not address the
specific facts of her claim and
11
the primary contentions made by
[Class Counsel] in [its] September 8, 2005 letter were actually
litigated and have been either settled by CAP No. 11 or denied by
the Court in PTO [No.] 6099, both entered on March 31, 2006.
11
Finally, the Trust incorporated and attached the opposition it
filed in response to claimants' motion.
Ms. Hart disputed the Trust's final determination and
requested that her claim proceed through 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 Ms. Hart's claim should be paid.
On May 14, 2007, we issued
an Order to show cause and referred the matter to the Special
Master for further proceedings.
See PtO No. 7194 (May 14, 2007).
-7-
Once the matter was referred 1to the Special Master, the
Trust submitted its statement of the case and supporting
documentation.
Claimant then served a ,response upon the Special
Master, incorporating by reference the .materials she submitted in
contest.
The Trust did not reply.
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.
Rule 30.
See Audit
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 issues presented for resolution of this claim are
whether claimant has met her burden of proving that there is a
reasonable medical basis for the attesting physician's findings
that she suffered from moderate mitral regurgitation and an
abnormal left atrial dimension and, if so, whether she also has
met her burden of proving that her claim was not based, in whole
or in part, on any intentional material misrepresentation of
fact.
See id. Rule 24.
Ultimately, if we determine that there
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 y. 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.
-8-
is no reasonable medical basis for the answers in claimant's
Green Form that are at issue or that
a~
intentional material
misrepresentation of fact was made in qonnection with the claim,
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 answers and that there was not an intentional
material misrepresentation of fact made in connection with the
claim, 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. Vigilante, reviewed
claimant's echocardiogram and concluded that it was not conducted
in a manner consistent with medical standards.
Specifically,
Dr. Vigilante observed:
The color flow portion of the study was of
poor quality.
There was clear evidence of
excessive color gain. There was color
artifact noted in the myocardium.
In
addition, the supposed mitral regurgitation
jet consisted of significant color artifact
with excessive gain. The Nyquist limits
appeared to be appropriately set. However,
the low velocity reject was only 2.6 em per
second.
Despite these deficiencies, Dr. Vigilante noted that he
was able to evaluate claimant's echocardiogram and determined
that there was no reasonable medical basis for the attesting
physician's finding that claimant had moderate mitral
regurgitation.
Dr. Vigilante explained, in pertinent part, that:
-9-
There were several supposed ~egurgitant jet
areas measured by the sonogr~pher. These
measurements included 5.92 cm2, 6.03 cm2,
5.13 cm2, 5.55 cm2, and 5.30 cm2. These
supposed RJA's are inaccurate. A portion of
these measurements include backflow as these
measurements were taken during the latter
part of the QRS complexes and at the
beginning of systole.
In real time, the true
RJA is much smaller. Visually, the degree of
mitral regurgitation appears mild.
I
digitized those cardiac cycles in the apical
four chamber view in which the mitral
regurgitation appeared most severe.
I was
able to accurately planimeter the RJA in the
midportion of systole. The largest RJA was
4.1 cm2 in spite of the excessive color gain.
I was able to exclude backflow and low
velocity flow artifact in my measurement.
The true LAA was 24.0 cm2. The measurement
of the supposed LAA of 21.1 cm2 by the
sonographer was inaccurate and did not
completely include the posterolateral portion
of the left atrium.
Therefore, the RJA/LAA
ratio was no greater than 17.1% in those
cardiac cycles in which the mitral
regurgitation appeared most severe. The
accurately measured RJA/LAA ratio did not
come close to approaching 20%.
After reviewing the entire show cause record, we find
claimant has not established a reasonable medical basis for the
attesting physician's finding that she had moderate mitral
regurgitation.
In reaching this determination, we are required
to apply the standards delineated in the Settlement Agreement and
Audit Rules.
In the context of those two documents, we
previously have explained that conduct "beyond the bounds of
medical reason" can include:
loops and still frames;
(1) failing to review multiple
(2) failing to have a Board Certified
Cardiologist properly supervise and interpret the echocardiogram;
(3) failing to examine the regurgitant jet throughout a portion
-10-
of systole;
(4) over-manipulating echoeardiogram settings;
(5) setting a low Nyquist limit;
(6)
c~aracterizing
"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.
See Mem. in Supp. of PTO No. 2640 at 9-13, 15, 21-22, 26
(Nov. 14, 2002).
Here, Dr. Kisslo and Dr. Vigilante found that
claimant's sonographer improperly selected, traced, and measured
a supposed regurgitant "jet" that occurred too early in systole
and consisted of backflow rather than true high velocity
sustained regurgitant flow.
In addition, Dr. Vigilante
determined that the sonographer improp~rly included low velocity
flow in his measurement of claimant's RJA.
Dr. Kisslo and
Dr. Vigilante also concluded that the sonographer underestimated
claimant's LAA, which artificially increased the level of
Ms. Hart's regurgitation.
Finally, Dr. Kisslo and Dr. Vigilante
found that the echocardiogram of attestation was not conducted in
a manner consistent with medical standards because, among other
things, the echocardiogram settings included clear evidence of
excessive color gain and decreased low velocity reject.
Notwithstanding these deficiencies, Dr. Kisslo and
Dr. Vigilante determined that Ms. Hart's echocardiogram
demonstrated only mild mitral regurgitation.
In addition,
Dr. Vigilante concluded, after a thorough review, that there was
no reasonable medical basis for the attesting physician's opinion
-11-
that Ms. Hart had moderate mitral regurgitation. 10
Specifically,
he explained that "the RJA/LAA ratio was no greater than 17.1% in
those cardiac cycles in which the mitral regurgitation appeared
most severe" and that "[t]he accurately measured RJA/LAA ratio
did not come close to approaching 20%."
Furthermore, claimant offers little substantive
challenge to these findings aside from the largely conclusory
opinions of Dr. Fowles.
For example, while Dr. Fowles states
that he disagrees with Dr. Kisslo's determinations based on the
frames he reviewed, he does not identify any particular frame
demonstrating any improper conduct.
Moreover, although Ms. Hart
refers to documents that contend Dr. Kisslo lacked the requisite
independence to validate his findings, she makes no such
contention against Dr. Vigilante, an independent cardiologist
appointed by the court who reached similar conclusions during a
separate review.
Without identifying some specific error by the
Trust's expert and the Technical Advisor, claimant cannot meet
her burden of proof in establishing that her claim is payable.
We also reject claimant's argument that she should be
paid because her claim passed a second audit pursuant to PTO
No. 5632.
The plain language of the Audit Rules expressly
provides that the Trust must conduct a review separate from the
auditing cardiologist with respect to whether there were any
intentional material misrepresentations of fact in connection
10. Despite an opportunity to do so, Ms. Hart did not submit a
response to the Technical Advisor Report. See Audit Rule 34.
-12-
with a claim.
Specifically, the Audit Rules state, in pertinent
part, that:
The Auditing Cardiologist shall review a
Claim in accordance with these Rules to
determine whether there was a reasonable
medical basis for each answer in Part II of
the GREEN Form that differs from the Auditing
Cardiologist's finding on that specific issue
("GREEN Form Question at Issue"). The Trust
shall review a Claim to determine whether
there were any intentional material
misrepresentations made in connection with
the Claim. The Trust may consider
information from other Claims in Audit to
determine the existence of facts or a pattern
of misrepresentations implicating intentional
misconduct by an attorney and/or physician
that may warrant relief pursuant to Section
VI.E.8 of the Settlement Agreement.
Audit Rule 5.
Based on the findings of Dr. Kisslo, the Trust
denied Ms. Hart's claim, determining that the claim was based on
one or more intentional material misrepresentations of fact.
Ms. Hart disputed this determination and proceeded to
the show cause process.
We need not determine whether there was,
in fact, any intentional material misrepresentation of fact in
connection with Ms. Hart's claim given our conclusion, based on
our review of the entire record, that there is no reasonable
medical basis for Dr. Brann's representation that claimant had
moderate mitral regurgitation. 11
11. As we previously have stated, "[s]imply because an
undeserving claim has slipped through the cracks so far is no
reason for this court to put its imprimatur on a procedure which
may allow it to be paid." Mem. in Supp. of PTO No. 5625 at 6-7
(Aug. 24, 2005).
In this same vein, we will not ignore the
findings of other cardiologists who determined that there is no
reasonable medical basis for a claim simply because the claim has
(continued ... )
-13-
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
Ms. Hart's claim for Matrix Benefits.
11.
( ... continued)
previously passed audit.
-14-
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