BROWN, et al v. AMERICAN HOME PROD, et al
Filing
4868
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9127 RE: CLAIMANT KAREN BONZON. SIGNED BY HONORABLE HARVEY BARTLE, III ON 8/12/2013; 8/12/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110084 IN 11-MD-1203). (tjd)
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IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: DIET DRUGS (PHENTERMINE/
FENFLURAMINE/DEXFENFLURAMINE)
PRODUCTS LIABILITY LITIGATION
MDL NO. 1203
THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.
CIVIL ACTION NO. 99-20593
v.
AMERICAN HOME PRODUCTS
CORPORATION
2:16 MD 1203
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.
ll
August
Bartle, J.
,J.,
2013
Karen Bonzon ("Ms. Bonzon" 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
Ms. Bonzon has demonstrated a reasonable medical basis to support
her claim for Matrix Compensation Benetits ("Matrix Benefits")
and, if so, whether she met her burden of proving that her claim
1. Prior to March 11, 2002, Wyeth was known as American Home
Products Corporation.
In 2009, Pfizer Inc. acquired Wyeth.
2. Dennis Bonzon, Ms. Bonzon's spouse; also has submitted a
derivative claim for benefits.
was not based, in whole or in part, on any intentional material
misrepresentation of fact. 3
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 November, 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.
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
Settlement Agreement§§ IV.B.2.b. & IV,B.2.d. (1)-(2). Matrix A-1
describes the compensation available tq 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, Mat~ix B-1 outlines the
compensation available to Diet Drug Reyipients 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 wquld make it difficult for
them to prove that their VHD was caused solely by the use of
these Diet Drugs.
-2-
Based on an echocardiogram dated September 20, 2002, Dr. Brann
attested in Part II of claimant's Green Form that Ms. Bonzon
suffered from moderate mitral regurgitation and an abnormal left
atrial dimension. 4
Based on such findings, claimant would be
entitled to Matrix A-1, Level II benefits in the amount of
$471,345. 5
In the report of claimant's echocardiogram, Dr. Brann
stated that Ms. Bonzon had moderate mitral regurgitation of 31%.
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
59 mm in the supero-inferior dimension and 43 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
4. Dr. Brann also attested that claimant suffered from mild
aortic regurgitation and had New York ~eart Association
Functional Class III symptoms. These conditions are not at issue
in this claim.
5. 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 o~ severe mitral
regurgitation and one of five complicading factors delineated in
the Settlement Agreement. See Settlem~nt Agreement
§ IV.B.2.c. (2) (b).
An abnormal left a~rial dimension is one of
the complicating factors needed for a ~evel II claim.
-3-
than 4.0 em in the parasternal long axis view.
§
See id.
IV . B . 2 . c . ( 2 ) (b) i i ) .
In February, 2006, the Trust forwarded the claim for
review by Issam A. Mikati, M.D., F.A.C.C., F.A.H.A., F.A.S.E.,
one of its auditing cardiologists. 6
In audit, Dr. Mikati "graded
the [mitral regurgitation] as mild to moderate" and noted that
Ms. Bonzon's left atrial dimension "measurement was right at
[the] cutoff."
Dr. Mikati 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
6. The Trust originally forwarded the claim for review by one of
its auditing cardiologists in or around February, 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 proqessing of claims pending
implementation of the Seventh Amendment to the Settlement
Agreement. After the stay was lifted, ~we entered Pretrial Order
("PTO") No. 5632, which allowed the Trust to re-audit Matrix
claims that were reviewed by auditing Gardiologists but for which
the Trust had not issued post-audit de~erminations.
The Matrix
claims that were subject to re-audit included Ms. Bonzon's claim.
1
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September 19, 2006 declaration, Dr. Kisslo determined, in
pertinent part, that:
In Ms. Bonzon's study, the use of high color
gain, high image gain, color persistence,
decreased low velocity reject, decreased
velocity scale (PRF and Nyquist), and color
pixels dominant over anatomy, the selection
and planimetry of backflow, and the
overmeasurement of the mitral "jet," as well
as the undermeasurement of the left atrial
area and the overmeasurement of the left
atrial dimension are the result of deliberate
choices and conduct engaged in by the
sonographer performing this $tudy and at a
minimum, acquiesced in by the Attesting
Physician. Each of these ma~ipulations
exaggerated or created the appearance of
regurgitation, jet duration or a complicating
factor.
Thus, notwithstanding Dr. Mikati•s findings at audit,
the Trust issued a post-audit determination denying Ms. Bonzon's
claim based on its conclusion that there was substantial evidence
of intentional material misrepresentation of fact in connection
with the claim.
Pursuant to the Audit'Rules, Ms. Bonzon disputed
this adverse determination. 7
In contest, claimant noted that she
did not dispute the findings of the Trust's two auditing
cardiologists who determined there was a reasonable medical basis
for her claim.
She also attached a September 8, 2005 letter from
7. Claims placed into audit on or bef~re December 1, 2002 are
governed by the Policies and Procedure$ 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. Bonzon's claim.
-5-
Class Counsel to the Trust 8 and a motion filed on behalf of
Ms. Bonzon and a number of other claimants represented by
Ms. Bonzon's law firm to enforce PTO No. 5632 or to set aside PTO
No. 5632 and to compel production of certain Trust documents. 9
The Trust then issued a final post-audit determination,
again denying Ms. Bonzon's claim.
The,Trust noted that
claimant's contest did not include any new medical evidence in
support of Ms. Bonzon's claim.
In addition, the Trust asserted
that Ms. Bonzon did not make any attempt to explain or deny
Dr. Kisslo's determination that there was substantial evidence of
intentional material misrepresentations of fact made in
connection with her claim.
The Trust also contended that Class
Counsel's letter could not support Ms. Bonzon's claim for
benefits because it did not address the specific facts of her
claim and "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
8.
In this letter, Class Counsel argued, among other things,
that the Trust could not deny payment qn 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).
9. We subsequently denied the motion.
No. 9114, at 6 n.8 (July 23, 2013).
-6-
See Mem. in Supp. of PTO
[No.] 6099, both entered on March 31, 2006."
Finally, the Trust
incorporated and attached the oppositi0n it filed in response to
claimant's motion.
Ms. Bonzon 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. Bonzon's claim should be paid.
issued an Order to show cause and
On May 14, 2007, we
refe~red
Special Master for further proceedings;
the matter to the
See PTO No. 7194
(May 14, 2007).
Once the matter was referredito 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 10 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
10. 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." Rei#ly 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.
-7-
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.
~Audit
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 finding
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,
i~
we determine that there
is no reasonable medical basis for the answers in claimant's
Green Form that are at issue or that an intentional material
misrepresentation of fact was made in connection with the claim,
we must affirm the Trust's final determination and may grant such
other relief as deemed appropriate.
S§e 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
-8-
in a manner consistent with medical standards.
Specifically,
Dr. Vigilante observed:
[T]he images were not conducted in a manner
consistent with medical standards. There was
excessive two dimensional echo gain with
distortion of the cardiac st~uctures.
There
was obvious excessive color gain causing
artifact within the tissue. The pulse
repetition frequency was dec~eased from 4,000
to 3,500 Hz with the Nyquist limit decreased
from 70 to 61 during the time that the mitral
regurgitation jet was being evaluated in the
apical view.
In addition, it was noted that
the low velocity reject setting was 2.5 em
per second. There was no apparent imaging
issue that would cause the sonographer to
change these settings.
Despite these deficiencies,
~r.
Vigilante noted that he
was able to evaluate claimant's echocardiogram and he 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:
Visually, only mild mitral r~gurgitation was
appreciated .... I digitized•those cardiac
cycles in which the mitral regurgitation jet
appeared most significant in the apical
4 chamber view.
I measured the RJA and LAA
in these cardiac cycles.
In spite of
increased artifact involved in the color flow
evaluation, I was able to accurately measure
several RJA's in the mid portion of systole.
The RJA was less than 3.2 cm2 in those
cardiac cycles in which the mitral
regurgitation appeared most impressive. Most
of the cardiac cycles had RJA values less
than 3.2 cm2.
I was able to accurately
measure the LAA and found this to be
20.4 cm2. Therefore~ the RJA/LAA ratio was
less than 16% in those cardiac cycles in
which the mitral regurgitation appeared most
severe. The majority of cardiac cycles
demonstrated RJA/LAA ratios ~uch less than
16%. The sonographer made t~ree measurements
of the supposed RJA.
These measurements were
I
-9-
6.12 cm2, 5.97 cm2, and 7.03 cm2. These
measurements were grossly inaccurate as they
all occurred at the very beginning of systole
and included backflow as well as tracings of
flow on the left ventricular side of the
mitral valve.
In addition, these
planimetered areas included ~on-mitral
regurgitation low velocity flow.
After reviewing the entire show cause record, we find
claimant has not established a
reasona~le
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 have
previously explained that 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
Nyquist limit;
s~ttings;
(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.
See
Mem. in Supp. of PTO No. 2640 at 9-13, 15, 21-22, 26
(Nov. 14, 2002).
Here, Dr. Kisslo and Dr.
Vig~lante
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
-10-
rue high velocity
sustained regurgitant flow.
In addition, Dr. Vigilante
determined that the sonographer improperly included backflow,
tracings of flow on the left ventricular side of the mitral
valve, and non-mitral regurgitation low velocity flow.
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 ex¢essive color gain and
decreased low velocity reject.
Notwithstanding these deficiencies, Dr. Kisslo and
Dr. Vigilante determined that Ms. Bonzon'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
that Ms. Bonzon had moderate mitral regurgitation. 11
Specifically, he explained that "the RJA/LAA ratio was less than
16% in those cardiac cycles in which the mitral regurgitation
appeared most severe" and that "[t]he majority of cardiac cycles
demonstrated RJA/LAA ratios much less than 16%."
Claimant does not substantively challenge the specific
findings of Dr. Kisslo and Dr. Vigilantte regarding the manner in
which her echocardiogram was conducted or her level of mitral
regurgitation was evaluated.
Rather, claimant refers to
documents that contend Dr. Kisslo lacked the requisite
independence to validate his findings.
Notably, Ms. Bonzon makes
11. Despite an opportunity to do so, Ms. Bonzon did not submit a
response to the Technical Advisor Repo~t. See Audit Rule 34.
I
-11-
no such contention against Dr. Vigilante, an independent
cardiologist appointed by the court who reached a similar
conclusion 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 arsument 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
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 cQnnection with
the Claim. The Trust may consider
information from other Claim~ 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
ot Dr. Kisslo, the Trust
denied Ms. Bonzon's claim, determining that the claim was based
on one or more intentional material misrepresentations of fact.
-12-
Ms. Bonzon disputed this determination and proceeded to
the show cause process.
We need not determine whether there was,
in fact, any intentional material misr¢presentation of fact in
connection with Ms. Bonzon'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. 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
Ms. Bonzon's claim for Matrix Benefits and the related derivative
claim submitted by her spouse.
12. As we previously have stated, "[siimply because an
undeserving claim has slipped through the cracks so far is no
reason for this court to put its impriroatur 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, w~ will not ignore the
findings of other cardiologists who determined that there is no
reasonable medical basis for a claim s~mply because the claim has
previously passed audit.
-13-
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