BROWN, et al v. AMERICAN HOME PROD, et al
Filing
4880
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9134 RE: CLAIMANT DONNA M. RIVAS. SIGNED BY HONORABLE HARVEY BARTLE, III ON 8/21/2013; 8/21/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110096 IN 11-MD-1203). (tjd)
<![CDATA[
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.
v.
AMERICAN HOME PRODUCTS
CORPORATION
)
)
)
)
)
)
)
)
)
)
CIVIL ACTION NO. 99-20593
2:16 MD 1203
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER
Bartle, J.
No.Cfl~
August
l I,
2013
Donna M. Rivas ("Ms. Rivas" 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
claimant has demonstrated a reasonable medical basis to support
her claim for Matrix Compensation Benefits ("Matrix Benefits") . 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
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
(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 must complete Part III
if claimant is represented.
In March, 2010, claimant submitted a completed Green
Form to the Trust signed by her attesting physician, Paul W.
Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A.
Based on an
echocardiogram dated June 28, 2002, Dr. Dlabal attested in
Part II of claimant's Green Form that Ms. Rivas suffered from
mild aortic regurgitation and moderate mitral regurgitation and
had surgery to repair or replace the aortic and/or mitral
valve(s) following the use of Pondimin® and/or Redux™. 3
Based on
2.
( ... continued)
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.
3. Dr. Dlabal also attested that claimant suffered from an
abnormal left atrial dimension, a reduced ejection fraction in
the range of 50% to 60%, and New York Heart Association
(continued ... )
-2-
such findings, claimant would be entitled to Matrix A-1, Level
III benefits in the amount of $671,107. 4
In the report of claimant's echocardiogram, the
reviewing cardiologist, George G. Miller, M.D., F.A.C.C., stated
that claimant had moderate mitral regurgitation of 28%.
Under
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
§
I.22.
In August, 2010, the Trust forwarded the claim for
review by Alan Bier, M.D., one of its auditing cardiologists.
Dr. Bier accepted the attesting physician's representations that
claimant had mild aortic regurgitation, moderate mitral
regurgitation, and surgery to replace her aortic and mitral
valves.
Dr. Bier also determined, however, that there was no
reasonable medical basis for Dr. Dlabal's representation that
Ms. Rivas did not suffer from aortic sclerosis at the time she
was first diagnosed as FDA Positive. 5
3.
( ... continued)
Functional Class I symptoms.
in this claim.
Pursuant to Court Approved
These conditions are not at issue
4. Under the Settlement Agreement, a claimant is entitled to
Level III benefits if he or she suffers from "left sided valvular
heart disease requiring ... [s]urgery to repair or replace the
aortic and/or mitral valve(s) following the use of Pondimin®
and/or Redux™." Settlement Agreement § IV.B.2.c. (3) (a).
5. Under the Settlement Agreement, the presence of aortic
sclerosis in claimants who were sixty (60) years of age or older
at the time they were first diagnosed as FDA Positive requires
(continued ... )
-3-
Procedure ("CAP") No. 11, the Consensus Expert Panel 6
subsequently reviewed the claim and determined that it should be
re-audited because the "[g]roup does not find [a]
medical basis]
[reasonable
for [the] auditor['s] findings of no [mitral
annular calcification] and moderate [mitral regurgitation] ." 7
In
November, 2010, the Trust informed Ms. Rivas that it had accepted
the Consensus Expert Panel's recommendation that her claim be
re-audited.
In November, 2010, the Trust forwarded the claim for
review by another auditing cardiologist, M. Michele Penkala, M.D.
Dr. Penkala concluded that there was a reasonable medical basis
for the attesting physician's findings that claimant had mild
aortic regurgitation and surgery to replace her aortic and mitral
valves.
Dr. Penkala also determined, however, that there was no
5.
( ... continued)
the payment of reduced Matrix Benefits for claims based on damage
to the aortic valve.
See Settlement Agreement
§ IV.B.2.d. (2) (c)i)c).
FDA Positive is defined, in pertinent
part, as "mild or greater regurgitation of the aortic valve .... "
See id. § I.22.a.
6. The Consensus Expert Panel consists of three cardiologists,
one designated by each of Class Counsel, the Trust, and Wyeth.
See Pretrial Order ("PTO") No. 6100 (Mar. 31, 2006). We approved
creation of the Consensus Expert Panel to "monitor the
performance of the Auditing Cardiologists and to develop
procedures for quality assurance in the Audit of Claims for
Matrix Compensation Benefits." Id.
7. Under the Settlement Agreement, the presence of mitral
annular calcification requires the payment of reduced Matrix
Benefits for claims based on damage to the mitral valve.
See
Settlement Agreement § IV.B.2.d. (2) (c)ii)d).
Given our
disposition with respect to claimant's level of mitral
regurgitation, we need not reach this issue.
-4-
reasonable medical basis for Dr. Dlabal's representation that
Ms. Rivas did not aortic sclerosis at the time she was first
diagnosed as FDA Positive and that there was no reasonable
medical basis for Dr. Dlabal's finding that claimant had moderate
mitral regurgitation.
Specifically, Dr. Penkala observed:
The claimant appears to have had at most
trace/trivial [mitral regurgitation] present
prior to the end of the screening period.
The putative [mitral regurgitation] jets that
were traced clearly demonstrate low velocity
brief duration flow limited to early systole
consistent with typical "backflow." These
jets are seen during the early systolic
"red-blue" portion of the cardiac cycle.
The
[color wave] signal also demonstrates only
very minimal early systolic flow. 8
Based on Dr. Penkala's findings that claimant had mild
aortic regurgitation, surgery to replace her aortic valve, and
aortic sclerosis at the time she was first diagnosed as FDA
Positive, the Trust issued a post-audit determination that
Ms. Rivas was entitled only to Matrix B-1, Level III benefits.
The Trust also determined that claimant was not eligible to
receive benefits for damage to her mitral valve because she did
not have an echocardiograrn that demonstrated the presence of at
least mild mitral regurgitation between the time of Diet Drug use
and the end of the Screening Period.
Pursuant to the Rules for
the Audit of Matrix Compensation Claims ("Audit Rules"), claimant
8. As noted in the Report of Auditing Cardiologist Opinions
Concerning Green Form Questions at Issue, trace, trivial, or
physiologic regurgitation is defined as a "[n]on-sustained jet
immediately (within 1 ern) behind the annular plane of <+ 5%
RJA/LAA. II
-5-
contested this adverse determination. 9
In contest, Ms. Rivas
disputed Dr. Penkala's determination that claimant's level of
mitral regurgitation was less than moderate. 10
Ms. Rivas argued
that Dr. Penkala did not properly apply the standards set forth
in the Settlement Agreement.
She also contended that the Trust
improperly submitted her claim to the Consensus Expert Panel
because it was not satisfied with Dr. Bier's conclusions.
Ms.
Rivas also asserted there was a reasonable medical basis for Dr.
Dlabal's determination that Ms. Rivas had moderate mitral
regurgitation.
In support, Ms. Rivas submitted declarations from
Michael E. Staab, M.D., F.A.C.C., Leon J. Frazin, M.D., F.A.C.C.,
and Dr. Dlabal.
Dr. Staab stated, in relevant part, as follows:
4.
On the basis of my review of this study,
I found moderate mitral regurgitation (MR) .
5.
I re-measured the left atrial area
(LAA), and I found that it measured 19.7 cm 2 •
6.
The mitral regurgitant jet area (RJA)
was accurately measured at time 12:13:22 and
12:13:49, where the RJAs measured 4.2 cm2 and
3.8 cm2 , respectively.
7.
Accordingly, the RJA/LAA ratio was in
the moderate range (RJA/LAA = 21.32%) at time
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
PTO No. 2807 (Mar. 26, 2003). There is no dispute that the Audit
Rules contained in PTO No. 2807 apply to this claim.
10. Ms. Rivas did not contest the Trust's determination that she
only was entitled to Matrix B benefits on her claim for damage to
her aortic valve based on the Trust's finding that she had aortic
sclerosis as of the time she was first diagnosed as FDA Positive.
-6-
12:13:22, and the RJA/LAA ratio was close to
the moderate range (RJA/LAA = 19.29%) at time
12:13:49. The average of the two ratios was
in the moderate range (RJA/LAA avg. =
20.30%).
8.
The jets that I identified as showing
moderate and close-to-moderate regurgitation
were representative of the level of
regurgitation seen throughout the study, and
these jets represented true regurgitation at
the levels specified.
9.
I also reviewed the Attestation of
Auditing Cardiologist dated 11/29/10, and I
could easily refute all of the opinions which
were expressed in Section II of that
attestation.
10. Clearly, the regurgitant jets that I
found were typical holosystolic jets. They
were not low velocity and they were not
backflow.
Dr. Frazin observed, in pertinent part, that:
4.
On the basis of my review of this study,
I found moderate mitral regurgitation (MR),
which was best seen in the apical 2-chamber
view.
5.
The left atrial area (LAA) was measured
at 22 cm2 , at time 12:16:45.
6.
Regurgitant jet areas (RJAs) were
accurately measured at four (4) different
times, as follows:
RJA
RJA
RJA
RJA
=
=
=
=
6.51
7.11
6.21
7.17
cm2
cm2
cm2
cm2
at
at
at
at
12:16:19
12:16:40
12:16:59
12:17:17
7.
Accordingly, the RJA/LAA ratios were
29.59%, 32.32%, 28.23%, and 32.59%, with an
average of 30.68%.
8.
The jets that I identified as showing
moderate regurgitation were representative of
the level of regurgitation seen throughout
-7-
the study, and they represented true
regurgitation at the moderate level.
9.
I also reviewed the attestation of
Auditing Cardiologist dated 11/29/10.
10.
In contrast to the opinions of the
Auditing Cardiologist, the moderate mitral
regurgitant jets were not consistent with any
backflow, because the regurgitant jet plume
traveled to almost 75% of the
superior-inferior [sic] length of the left
atrium. With the Nyquist limit appropriately
set, the regurgitant jets revealed aliasing,
or were beyond aliasing at their distal
portions.
Finally, Dr. Dlabal stated, in pertinent part, that:
4.
On the basis of my review of this study,
I found moderate mitral regurgitation (MR) .
5.
The left atrial area (LAA) was measured
at 23.5 cm2 • This measurement was excessive,
because it included pulmonary veins and the
appendiceal ridge.
Therefore, I re-measured
the LAA, and I found that it measured
20.0 cm2 •
6.
In the apical 4-chamber view,
regurgitant jet areas (RJAs) were accurately
measured at four (4) different times, as
follows:
RJA = 4.21 cm2
RJA = 4.30 cm2
RJA = 3.84 cm2
RJA = 4.34 cm2
RJA Average =
at 12:13:00
at 12:13:23
at 12:13:47
at 12:14:20
4.17 cm2
7.
Accordingly, in the apical 4-chamber
view, RJA/LAA ratios were 21.0%, 21.5%,
19.2%, and 21.7%, with an average of 20.8%.
8.
However, moderate [mitral regurgitation]
was best seen in the apical 2-chamber view.
In that view, RJAs were accurately measured,
as follows:
RJA
RJA
=
=
6.5 cm2 at 12:16:18
7.1 cm2 at 12:16:41
-8-
RJA
RJA
RJA
RJA
= 6.2 cm2
= 7.2 cm2
= 7.0 cm2
Average =
at 12:16:58
at 12:17:17
at 12:17:30
6.8 cm 2
9.
Accordingly, in the apical 2-chamber
view, RJA/LAA ratios were 32.5%, 35.5%,
31.0%, 36.0%, and 35.0%, with an average of
34.0%.
10. The jets that I identified as showing
moderate [mitral regurgitation] were
representative of the level of regurgitation
seen throughout the study, and they
represented true regurgitation at the
moderate level.
11.
I also reviewed the Attestation of
Auditing Cardiologist dated
November 29, 2010.
12.
In rebuttal to the Auditing
Cardiologist's Attestation, there is no
possible argument for "backflow" in this
case.
13. Backflow jets are rarely measured due to
their small sizes, but if measured, backflow
jets would be expected to have RJA/LAA ratios
of no more than 1 to 5%. Backflow jets would
not have average ratios of 20.8% and 34.0%,
as in this case.
14. Further, the jets that I found were
predominately multi-colored, indicating
aliasing. Also, the edges of the jets were
irregular. These features singly and
together confirm the pathological nature of
the jets, as opposed to backflow which-when
present-is a physiological phenomenon.
Accordingly, Ms. Rivas argued that she was entitled to Matrix A1, Level III benefits for her mitral valve claim. 11
11.
If claimant's level of mitral regurgitation was determined
to be moderate, Ms. Rivas would be entitled to Matrix A-1, Level
III benefits.
If, however, claimant's level of mitral
regurgitation was determined to be mild, Ms. Rivas would be
(continued ... )
-9-
Although not required to do so, the Trust forwarded the
claim for a second review by the auditing cardiologist.
Dr. Penkala submitted a declaration in which she again concluded
that there was no reasonable medical basis for the attesting
physician's finding that Ms. Rivas had moderate mitral
regurgitation.
Dr. Penkala stated, in relevant part, that:
7.
In light of Claimant's Contest, I was
contacted by the Trust and asked to
review Claimant's Contest Materials, as
well as Claimant's June 28, 2002
echocardiogram tape.
8.
In accordance with the Trust's request,
I reviewed the Claimantts claim file and
medical records, and the June 28, 2002
echocardiogram tape.
I also reviewed
Claimant's Contest Materials, including
the declarations of Drs. Staab, Frazin
and Dlabal.
9.
I confirm my finding at audit that there
is no reasonable medical basis to
conclude that Claimant had moderate
mitral regurgitation at the time of the
June 28, 2002 echocardiogram study.
10.
At Contest, I reviewed the entirety of
the June 28, 2002 echocardiogram study.
I also reviewed those specific points in
the study identified by Drs. Staab,
Frazin and Dlabal. Although the
claimant did eventually go on to develop
at least moderate mitral regurgitation,
as seen on her subsequent echo (9/20/08)
and heart [catheterization] (9/24/08),
there is no reasonable medical basis to
find moderate mitral regurgitation on
the study dated June 28, 2002.
11.
( ... continued)
entitled only to Matrix B-1, Level III benefits.
Agreement § IV.B.2.d. (2) (a).
-10-
See Settlement
11.
I reviewed those specific points in the
study, 12:13:22 and 12:13:49, where
Dr. Staab indicates moderate mitral
regurgitation is seen. At both of these
points in the study, very early systolic
flow of brief duration is seen during
the 'red-blue' period, which is
consistent with backflow. At 12:15:10,
the Color Wave Doppler mitral
regurgitation signal clearly
demonstrates very early systolic flow
ONLY, and there is no evidence
whatsoever to support a finding of
"typical holosystolic jets" described by
Dr. Staab in his statement.
12.
Dr. Frazin states that moderate mitral
regurgitation is best seen in the
"apical 2-chamber view," and identifies
four frames where he says moderate
mitral regurgitation is present:
12:16:19, 12:16:40, 12:16:59 and
12:17:17. I reviewed the June 28, 2002
tape with specific attention to these
frames.
Each of these frames
demonstrates brief duration early
systolic flow at the very beginning of
the QRS complex. The 12:16:19 and
12:16:40 frames are taken from the
apical 2-chamber view and, along with
the other two frames, clearly
demonstrate flow characteristic of
physiologic backflow.
13.
I disagree with Dr. Frazin's statement
that the flow seen in these frames
cannot be backflow because "the
regurgitant jet plume traveled to almost
75% of the superior-inferior [sic]
length of the left atrium," and because
there is "aliasing" of the regurgitant
jets. Backflow describes physiologic
displacement of blood in the left atrium
as the mitral valve closes in
end-diastole. The [mitral
regurgitation] identified here is brief
duration early systolic flow at the very
beginning of the QRS complex.
Further,
this study was recorded on a Cypress
machine, a portable device which tends
to make the jets appear more mosaic than
-11-
they would on a more conventional
non-portable device.
This appears to be
the case on this recording.
14.
I also reviewed the tape with specific
attention to the frames described by
Dr. Dlabal, who describes moderate
mitral regurgitation in several frames
in the apical 4-chamber (12:13:00,
12:13:23, 12:13:47 and 12:14:20) and
apical 2-chamber views (12:16:18,
12:16:41, 12:16:58, 12:17:17 and
12:17:30). I reviewed each of these
points in the study. Each occurs on the
QRS in very early systole during the
'red-blue' period of flow and is
consistent with very brief duration
backflow.
15.
disagree with Dr. Dlabal's assertion
that the 'regurgitation' present on this
study cannot be backflow. Dr. Dlabal
states that "backflow jets are rarely
measured due to their small sizes, but
if measured ... would be expected to
have RJA/LAA ratios of no more than
1-5%." Backflow is related to the
timing of the flow as well as the size.
Further, the size of a •jet' changes
based on the machine utilized, machine
settings, etc. While Dr. Dlabal
describes the "multi-colored ...
aliasing ... irregular" nature of the
jets and states that these findings
"confirm the pathological nature of the
jets," the •jet' appearance is a result
of this study being recording [sic] on a
Cypress machine.
16.
All of the jets identified at Contest as
representative of moderate mitral
regurgitation show backflow. There is
no evidence of mid- or late-systolic
mitral regurgitant flow.
When one looks
at the [left atrium] when the EKG is on
the T wave there is no regurgitant flow
whatsoever present. This finding is
confirmed with the [color wave] tracing
as described above.
I
-12-
The Trust then issued a final post-audit determination,
again determining that Ms. Rivas was entitled only to Matrix B-1,
Level III benefits for damage to her aortic valve and that
Ms. Rivas was not entitled to Matrix Benefits for damage to her
mitral valve.
Claimant disputed this 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 this claim should be paid.
On April 13, 2011, we issued an
Order to show cause and referred the matter to the Special Master
for further proceedings.
See PTO No. 8634 (Apr. 13, 2011).
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 3, 2011, and
claimant submitted a sur-reply on November 28, 2011.
Under the
Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor 12 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
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
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.
-13-
Technical Advisor, Sandra V. Abramson, 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 issue presented for resolution of this claim is
whether claimant has met her burden of proving that there is a
reasonable medical basis for the attesting physician's finding
that Ms. Rivas had moderate mitral regurgitation.
Rule 24.
See id.
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.
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).
In support of her claim, Ms. Rivas reasserts the
arguments made in contest.
Claimant also argues that the
reasonable medical basis standard requires that deference be
given to the conclusions of her attesting physician.
In
addition, Ms. Rivas argues that Dr. Penkala was neither qualified
to serve as an auditing cardiologist nor independent from the
-14-
Trust. 13
Finally, Ms. Rivas submitted a declaration of
Dr. Dlabal wherein he stated, in pertinent part, that:
2.
I am personally unaware of any
information suggesting that the Cypress
Echocardiograph is somehow known for
exaggerating Mitral Regurgitation.
It is a
member of the Accuson line of cardiac
ultrasound devices, which are widely regarded
as an industry standard.
3.
All echocardiographic devices sold in
the US are subject to FDA approval, and thus
are required to meet established standards.
If there were indeed any deviation from the
standards for acoustic imaging, this issue
would have been addressed in the development
of the machine.
4.
A literature search of this topic
produces no information to suggest that this
issue has been reported to the FDA, the
cardiovascular community, nor has even been
the topic of written discussion.
In response, the Trust argues that claimant did not
establish a reasonable medical basis for Dr. Dlabal's
representation of moderate mitral regurgitation because she did
not adequately rebut Dr. Penkala's determination that the
purported regurgitant jets identified by her cardiologists were
early in systole and constituted backflow.
In addition, the
Trust asserts that the findings of the attesting physician are
not entitled to deference and that the Trust properly applied the
reasonable medical basis standard.
The Trust also contends this
13. Claimant also asserted that the Trust did not comply with
Audit Rule 22, which requires the Trust to serve on the Special
Master the Trust's audit file and all materials submitted to
and/or completed by the auditing cardiologist. As nothing in the
record reflects the Trust did not comply with Audit Rule 22, this
argument is irrelevant.
-15-
claim was properly submitted for review by the Consensus Expert
Panel.
Finally, the Trust argues that Dr. Penkala meets the
requirements for appointment as an auditing cardiologist.
The Technical Advisor, Dr. Abramson, reviewed
claimant's echocardiogram and concluded that there was no
reasonable medical basis for the attesting physician's finding of
moderate mitral regurgitation.
Dr. Abramson explained:
In reviewing the transthoracic echocardiogram
from 6/28/02, my visual estimate is that
there is only mild mitral regurgitation.
I
measured the mitral regurgitant jet in five
different cardiac cycles.
I could not
measure the RJA and LAA in the same view
because the LAA was foreshortened in the
angle that was used to obtain the maximal
LAA.
I used a constant left atrial area of
23.5 cm2 , which was the LAA tracing on the
tape.
I chose tracings that were
representative of the mitral regurgitant jets
from multiple cardiac cycles from each of the
apical views. The measurements I used for
mitral regurgitant jet area are 4.2 cm 2 ,
4.1 cm 2 , 3.2 cm2 , 3.8 cm2 , and 4.3 cm2 , which
were measurements traced on the tape. These
ratios are 18%, 17%, 14%, 16%, and 18%, all
of which are less than 20%, which is
consistent with mild mitral regurgitation.
The continuous wave Doppler of the mitral
regurgitant jet was faint, which is
consistent with mild mitral regurgitation.
There were several larger tracings on the
tape that I did not use because they were
traced incorrectly. They were either
overtraced or included low-velocity,
non-regurgitant flow.
Dr. Dlabal chose to use a left atrial area of
20.0 cm2 for all of his ratios. This is a
normal left atrial area, yet he stated on the
Green Form that claimant has an abnormal left
atrial dimension.
I do not know why he chose
20 cm2 for his measurement of the left atrial
area. On the tape, the technologist traced
-16-
an accurate left atrial area measurement of
23.5 cm2 which appropriately excludes
pulmonary veins and left atrial appendage.
In response to the Technical Advisor Report, Ms. Rivas
argues that the Technical Advisor substituted her own opinion for
that of claimant's cardiologists and did not consider all of the
relevant evidence, including evidence supportive of claimant's
arguments.
Ms. Rivas also asserts that Dr. Abramson did not
evaluate claimant's mitral regurgitation in the apical two
chamber view, which Dr. Frazin and Dr. Dlabal said represented
the largest mitral regurgitation.
After reviewing the entire Show Cause Record, we find
the claimant's arguments are without merit.
Contrary to
claimant's assertion, the opinions of her cardiologists do not
provide a reasonable medical basis for her claim.
We are
required to apply the standards delineated in the Settlement
Agreement and Audit Rules.
The context of these 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.
As we previously explained in
PTO No. 2640, conduct "beyond the bounds of medical reason" can
include:
(1) failing to review multiple loops and still frames;
(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 the echocardiogram setting;
low Nyquist limit;
(5) setting a
(6) characterizing "artifacts," "phantom
-17-
jets,
11
11
backflow 11 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 , 2 0 0 2 ) .
Here, Dr. Penkala reviewed claimant's echocardiogram
and determined that it demonstrated only trace mitral
regurgitation.
She noted that the
11
jets that were traced clearly
demonstrate low velocity brief duration flow limited to early
systole consistent with typical 'backflow. '
11
Claimant submitted
declarations from three cardiologists, Dr. Staab, Dr. Frazin, and
Dr. Dlabal.
Dr. Staab identified one instance of moderate mitral
regurgitation and one instance of
11
close to the moderate range.
Dr. Penkala reviewed these two specific points in claimant's
echocardiogram.
She explained:
At both of these points in the study, very
early systolic flow of brief duration is seen
during the •red-blue' period, which is
consistent with backflow. At 12:15:10, the
Color Wave Doppler mitral regurgitation
signal clearly demonstrates very early
systolic flow ONLY, and there is no evidence
whatsoever to support a finding of 11 typical
holosystolic jets 11 described by Dr. Staab in
his statement.
Dr. Frazin stated the regurgitant jets he identified
were not backflow because
11
the regurgitant plume traveled to
almost 75% of the superior-inferior [sic] length of the left
atrium 11 and
11
the regurgitant jets revealed aliasing, or were
beyond aliasing at their distal portions.
-18-
11
Dr. Penkala
11
disagreed, observing that "[b]ackflow describes physiologic
displacement of blood in the left atrium as the mitral valve
closes in end-diastole."
regurgitation]
She explained, "The [mitral
identified here is brief duration early systolic
flow at the very beginning of the QRS complex."
Dr. Dlabal disputed that the jets he identified
included backflow because "backflow jets would be expected to
have RJA/LAA ratios of not more than 1 to 5%," rather than the
average 20.8% and 34.0% he measured in this case.
Dr. Dlabal
also stated that the jets on which he relied "were predominately
multi-colored, indicating aliasing" and that the irregular edges
of the jets confirms "pathological nature" of the jets. 14
Dr. Penkala disagreed with Dr. Dlabal's assertion, noting that
"[b]ackflow is related to the timing of the flow as well as the
size."
Significantly, despite the fact that Ms. Rivas submitted
a supplemental declaration of Dr. Dlabal in response to
Dr. Penkala's statement that a portable echocardiogram machine
exaggerates certain images on an echocardiogram, Dr. Dlabal did
14. Contrary to claimant's argument, Dr. Penkala never observed
that the jets on claimant's echocardiogram were "mosaic,
multi colored, aliasing, and irregular." In paragraphs 13 and 15
of her declaration, Dr. Penkala is remarking as to Dr. Frazin's
and Dr. Dlabal's determinations that the jets were "mosaic,
multi-colored, aliasing, and irregular." To the extent
Dr. Penkala observed these characteristics, she determined they
were a result of the machine on which claimant's echocardiogram
was performed. Dr. Dlabal's statement that he is unaware of the
effect a portable echocardiograph machine may have on an
echocardiogram does not adequately rebut Dr. Penkala's
determination.
-19-
not address Dr. Penkala's specific findings with respect to the
existence of backflow in his measurements or the measurements of
Dr. Staab and Dr. Frazin.
Dr. Abramson also reviewed claimant's echocardiogram
and determined that it did not demonstrate moderate mitral
regurgitation.
Dr. Abramson "chose tracings that were
representative of the mitral regurgitant jets from multiple
cardiac cycles from each of the apical views" and determined that
each RJA/LAA ratio was less than 20%, consistent with mild mitral
regurgitation. 15
Dr. Abramson noted that she did not rely on
larger tracings on the echocardiogram because "[t]hey were either
overtraced or included low-velocity, non-regurgitant flow."
Dr. Abramson also observed that Dr. Dlabal used a normal left
atrial area to calculate claimant's RJA/LAA despite the fact that
he noted claimant had an abnormal left atrial dimension.
A
smaller LAA would artificially increase the RJA/LAA ratio. 16
Such unacceptable practices by claimant's cardiologists cannot
provide a reasonable medical basis for the resulting diagnosis
15. For this reason, we reject claimant's argument that
Dr. Abramson did not evaluate claimant's mitral regurgitation in
the apical two chamber view.
16. Thus, we reject claimant's argument that Dr. Abramson
substituted her own opinion for that of claimant's cardiologists
and did not consider all of the relevant evidence, including
evidence supportive of claimant's arguments.
-20-
and Green Form representation that claimant suffered from
moderate mitral regurgitation. 17
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
the claim of Ms. Rivas for Matrix A benefits.
17.
For this reason as well, we reject claimant's argument that
she should prevail because the reasonable medical basis standard
requires that deference be given to the conclusions of her
attesting physician or that it is sufficient for the attesting
physician or claimant only to disagree with the auditing
cardiologist to establish a reasonable medical basis for her
claim.
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