BROWN, et al v. AMERICAN HOME PROD, et al
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9010 RE: CLAIMANT CYNTHIA CARR. SIGNED BY HONORABLE HARVEY BARTLE, III ON 2/27/2013; 2/27/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 109883 IN 11-MD-1203). (tjd)
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: DI:ET DRUGS (PHENTERMINE/
PRODUCTS LIABILITY LITIGATION
MDL NO. 1203
THIS DOCillo1ENT RELATES TO:
SHEILA BROWN, et al.
AMERICAN li-iOME PRODUCTS
CIVIL ACTION NO. 99-20593
2:16 MD 1203
IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.
Cynthia Carr ("Ms. Carr" or "claimant"), a class member
under the Diet Drug Nationwide Class Action Settlement Agreement
("Settlement Agreement") with Wyeth,
Settlement Trust ("Trust"). 2
seeks benefits from.the AHP
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
Prior to March 11, 2002, Wyeth was known as American Home
Harvey G. Carr, Ms. Carr'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 comp(:msation purposes based upon the severity of their
medical c:onditions, their ages when they are diagnosed, and the
presence of other medical conditions that also may have caused or
contribul:ed to a claimant's valvular heart disease ( "VHD") . See
(continued ... )
To seek Matrix Benefits, a claimant must first submit a
completed Green Form to the Trust.
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 • ~:: 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
Finally, claimant's attorney must complete Part III
if claimant is represented.
In April, 2003, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Malcolm P.
Dr. Taylor is no stranger to this litigation.
According to the Trust, he has signed at least 1,140 Green Forms
on behalf of claimants seeking Matrix Benefits.
Based on an
echocardiogram dated October 11, 2002, Dr. Taylor attested in
Part II o:E Ms. Carr • s Green Form that she suffered from moderate
mitral regurgitation and an abnormal left atrial dimension.
( ... 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
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.
Based on such findings, claimant would be entitled to Matrix
B-1, 4 Level II benefits in the amount of $107,795. 5
In the report of claimant's echocardiogram, Dr. Taylor
stated that there was" [m]ild to moderate mitral regurgitation
with RJA/LAA ratio 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").
See Settlement Agreement
Dr. Taylor also opined that the claimant's "[left atrium]
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.
IV . B . 2 . c . ( 2 ) (b) i i ) .
In September, 2005, the Trust forwarded the claim for
review by Maged M. Rizk, M.D., Ph.D., F.A.C.C., one of its
In audit, Dr. Rizk concluded that there
Claimant concedes that her claim is payable, if at all, on
the B Matrix because she ingested Diet Drugs for 60 days or less.
See Settl,ement Agreement § IV.B.2.d. (2) (b).
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). An abnormal left
atrial dimension is one of the complicating factors needed to
qualify for a Level II claim.
was no rec:Lsonable medical basis for Dr. Taylor • s finding that
claimant !:tad moderate mitral regurgitation because
regurgi tat:~ ion]
is seen in real time.
Dr. Rizk also concluded
was no reasonable medical basis for the attesting
physician'' s finding that claimant had an abnormal left atrial
dimension because the "[supero-inferior] diameter is
Based on Dr. Rizk's findings, the Trust issued a
post-audit determination denying Ms. Carr's claim.
the Rules for the Audit of Matrix Compensation Claims ("Audit
Rules") , c:laimant contested this adverse determination. 6
contest, c:laimant submitted a declaration of Jesse E. McGee,
M.D., F.A.C.C., wherein he opined that there does not appear to
be any overtracing of claimant's RJA or LAA and that "there is at
least a R,JA/LAA of 20% of the Mitral Valve."
claimant challenged the auditing cardiologist's failure to
as to claimant's level of mitral
regurgitation and argues that without such measurements she "is
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. Carr's claim.
put in a position where she can not [sic] contest the auditing
The Trust then issued a final post-audit determination
again denying Ms. Carr•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§ 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. Carr•s claim should be paid.
On May 30, 2006,
we issued an Order to show cause and referred the matter to the
for further proceedings.
See PTO No. 6341
(May 3 0 , 2 0 0 6 ) .
Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
Claimant then served a response upon the Special
The Trust submitted a reply on November 7, 2006.
the Audit Rules, it is within the Special Master•s discretion to
7. Dr. McGee also opined that there was a reasonable medical
basis for Dr. Taylor•s finding of an abnormal left atrial
dimension because claimant•s left atrial dimension was ••at least
5.93cm. 11 Claimant further argued that her echocardiogram tape
and report show that she had a left atrial measurement of 5.93
em, and that the auditing cardiologist•s opinion 11 is not reliable
or scientific and amounts to mere guesswork and it should not be
considered ... Given our disposition with regard to the level of
claimant•s mitral regurgitation, we need not decide whether
claimant has satisfied her burden of proving there is a
reasonable medical basis for Dr. Taylor•s representation that
claimant had an abnormal left atrial dimension.
appoint a Technical Advisor 8 to review claims after the Trust and
claimant have had the opportunity to develop the Show Cause
Audit Rule 30.
The Special Master assigned a
Technical Advisor, Gary J. Vigilante, M.D., F.A.C.C., to review
the docum(:!nts submitted by the Trust and claimant, and to prepare
a report :!:or the court.
The Show Cause Record and Technical
Advisor Rt':!port 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).
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).
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 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 opposition positions" is proper. Id.
In support of her claim, claimant reasserts the
arguments raised during contest, namely, that she should prevail
because t''m cardiologists found that Ms. Carr had moderate mitral
regurgitation and that the auditing cardiologist should be
required to provide measurements regarding his findings.
addition, claimant argues that "the auditing process is flawed"
and that '''the auditing cardiologists are not reviewing the cases
In response, the Trust argues that claimant's
supplemental expert report is insufficient to satisfy her burden
of establishing a reasonable medical basis for the conclusion
that she had moderate mitral regurgitation.
The Trust also
asserts that Dr. Rizk conducted the audit in accordance with the
Settlement Agreement and that the auditing cardiologist is not
required to provide specific measurements.
The Technical Advisor, Dr. Vigilante, reviewed
claimant's echocardiogram and concluded that there was no
reasonable medical basis for the attesting physician's findings
of moderate mitral regurgitation.
Specifically, Dr. Vigilante
In spite of this echocardiogram being a poor
study, I was able to assess the presence and
severity of mitral regurgitation in the early
to mid portion of systole. Visually, there
was no mitral regurgitation seen in the
parasternal long-axis view.
However, in the
apical views a small jet of mitral
regurgitation was seen in the early phase of
systole in several cardiac cycles. Visually,
trace to mild mitral regurgitation was
suggested in these apical views.
those cardiac cycles in the apical views in
which the mitral regurgitant jet was best
evaluated and appeared to be most severe.
then digitally traced and calculated the RJA
I was able to accurately planimeter
the RJA in the early to mid portion of
In both apical views, the mitral
regurgitant jet was a short jet that did not
reach the mid portion of the left atrium.
the apical four chamber view, the largest
representative RJA was 1.1 cm2. The LAA in
the apical four chamber view was 16.7 cm2.
Therefore, the largest representative RJA/LAA
ratio was less than 7%. The largest
representative RJA in the apical two chamber
view was 1.3 cm2. The LAA in the apical two
chamber view was 15.3 cm2. Therefore, the
largest representative RJA/LAA ratio was 8%.
Most of the RJA/LAA ratios in the apical
views were less than 5%. Therefore, the
RJA/LAA ratio never came close to approaching
There was one sonographer-determined
RJA in the apical four chamber view. This
measurement was 4.90 cm2. This measurement
was inaccurate and was a reflection of
backflow. This was not a mitral regurgitant
jet seen in real time. There were no
sonographer-determined RJA's in the apical
two chamber view.
In addition, there was one
sonographer-determined LAA of 20.55 cm2 in
the apical four chamber view. This was an
inaccurate determination as the tracing went
beyond the posterior wall of the left atrium.
The inaccurate sonographer-determined RJA and
LAA values are the same calculations
documented in Dr. Taylor's echocardiogram
In response to the Technical Advisor Report, claimant
argues that the Technical Advisor's findings support a diagnosis
of moderate mitral regurgitation because both the attesting
physician and the Technical Advisor found an RJA of 4.90cm 2 and
an LAA of either 20.53cm 2 or 20.55cm 2
"practically the exact
Ms. Carr also argues that the Technical
Advisor did not adequately support his conclusion that the
attesting cardiologist measured backflow or traced beyond the
posterior wall of the left atrium, and she argues that such a
finding is inconsistent with Dr. McGee's declaration, which noted
that there "appear[s]" to be no overtracing on the
After reviewing the entire Show Cause Record, we find
claimant's arguments are without merit.
First, claimant does not
adequately contest Dr. Rizk's finding that the attesting
physician 1 s diagnosis of moderate mitral regurgitation lacked a
reasonable medical basis because "no [mitral regurgitation]
seen in real time" on claimant 1 s echocardiogram.
opportunity in the contest period to present additional evidence
in support of her claim, Ms. Carr relies only on Dr. McGee 1 s
conclusory declaration, which states that claimant has "at least
a RJA/LAA of 20% of the Mitral Valve."
Dr. Taylor nor Dr. McGee addresses Dr. Rizk's finding that the
mitral re':::Jurgitation on which Dr. Taylor relied did not appear in
Claimant never identified any error in the auditing
Mere disagreement with the auditing
cardiologist without identification of specific errors by him or
her, however, is insufficient to meet a claimant's burden of
Moreover, we disagree with claimant that Dr. Rizk did
not adequately set forth the basis for his audit findings.
Although the Settlement Agreement specifies the percentage of
regurgitation needed to qualify as having moderate mitral
regurgitation, it does not specify that actual measurements must
be made on an echocardiogram.
As we explained in PTO No. 2640,
"' [e]yeballing' the regurgitant jet to assess severity is well
accepted in the world of cardiology."
(Nov. 14, 2002).
See PTO No. 2640 at 15
Claimant essentially requests that we write
into the Settlement Agreement a requirement that actual
measurements of mitral regurgitation be made to determine if a
claimant qualifies for Matrix Benefits.
There is no basis for
such a revision and claimant's argument is contrary to the
"eyeballing" standards we previously have evaluated and accepted
in PTO No. 2640. 9
We also disagree with claimant that the opinions of
Dr. Taylor and Dr. McGee provide a reasonable medical basis for
We are required to apply the standards delineated in
the Settlement Agreement and the Audit Rules.
The context of
those two documents leads us to interpret the reasonable medical
basis standard as more stringent than claimant contends, and one
that must be applied on a case-by-case basis.
For example, as we
previously explained in PTO No. 2640, 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
Claim.::mt's demand for specific measurements is particularly
hollow giv·en that her own supplemental expert, Dr. McGee, did not
provide a:n.y measurements and simply stated, without any
substanti·v·e discussion or analysis, that claimant had "at least a
RJA/LAA oE 20% of the Mitral Valve." In any event,
Dr. Vigilante, as part of his review, provided the specific
measurements of the level of claimant's mitral regurgitation.
Cardiologist properly supervise and interpret the echocardiogram;
(3) failing to examine the regurgitant jet throughout a portion
(4) over-manipulating echocardiogram settings;
(5) settin.g a low Nyquist limit;
(6) characterizing "artifacts,"
"phantom jets," "backflow" and other low velocity flow as mitral
(7) failing to take a claimant's medical history;
and ( 8) mrertracing the amount of a claimant's regurgitation.
See PTO No. 2640 at 9-13, 15, 21-22, 26.
Here, Dr. Rizk
determinet::i in audit, and Ms. Carr does not adequately dispute,
that claimant's level of mitral regurgitation was significantly
overestim<::tted because mitral regurgitation was not seen in
real-time on claimant's echocardiogram.
Dr. Vigilante reviewed claimant's echocardiogram and determined
that the one sonographer-determined RJA measurement of 4.90 cm 2
was inaccurate because it included backflow and it did not appear
in real time.
He also observed that the one sonographer-
determined LAA measurement of 20.55 cm 2 was inaccurate because
"the tracing went beyond the posterior wall of the left atrium."
Finally, Dr. Vigilante noted that these are the same measurements
Dr. Taylor included in his echocardiogram report.
not refute these specific findings.
Instead, she relies on
Dr. Taylor's echocardiogram report based on these inaccurate
measureme:nts and Dr. McGee's declaration that does not provide
any measurements of his own. 10
Measurements based on such
We disagree with claimant that Dr. McGee's observation that
(continued ... )
unacceptable practices cannot provide a reasonable medical basis
for the resulting diagnosis and Green Form representation of
moderate mitral regurgitation.
Claimant's argument that Dr. Vigilante's conclusions
provide a reasonable medical basis for her claim because he
determined the echocardiogram demonstrated an RJA of 4.90 cm 2 and
an LAA of 20.53 cm2 is misplaced because Dr. Vigilante did not
make any such determination.
To the contrary, he concluded that
the largest representative RJA in the apical four chamber view
was 1.1 cm 2 and the largest RJA in the apical two chamber view
was 1.3 cm 2 •
In addition, he determined the LAA in the apical
four chamber view was 16. 7 cm2 and 15. 3 cm2 in the apical two
Moreover, Dr. Vigilante specifically noted that
the sonographer's RJA measurement of 4.90 cm2 was inaccurate and
was a reflection of backflow, and that the sonographer's LAA
measurement of 20.55 cm2 was inaccurate because the tracing went
beyond the posterior wall of the left atrium.
Finally, we reject claimant's assertion that the
Trust's audit system is unfair to claimants.
It is claimant's
burden in the show cause process to show why she is entitled to
( ... continued)
there did not appear to be any over measurement of Ms. Carr's RJA
or LAA undermines Dr. Vigilante's findings.
As an initial
matter, Dr. McGee did not provide any of his own measurements.
In addition, Dr. McGee has submitted declarations on behalf of
several claimants in the show cause process.
has consisted of the same text, repeating claimant's name and the
date of the echocardiogram and noting that the RJA and LAA
measurements do not appear overtraced and that claimant has at
least a 20% RJA/LAA ratio.
See Audit Rule 24.
The audit and show cause
process, as approved by this court, provides claimant with notice
and an opportunity to present her evidence in support of her
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
Therefore, we will affirm the Trust's denial of
Ms. Carr's claim for Matrix Benefits and the related derivative
claim submitted by her spouse.
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