BROWN, et al v. AMERICAN HOME PROD, et al
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9318 RE: CLAIMANT THE ESTATE OF MICHAEL L. JONES. SIGNED BY HONORABLE HARVEY BARTLE, III ON 7/10/2014; 7/11/2014 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110365 IN 11-MD-1203). (tjd, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: DIET DRUGS (PHENTERMINE/
PRODUCTS LIABILITY LITIGATION
MDL NO. 1203
THIS DOCUMENT RELATES TO:
SHEILA BROWN, et al.
CIVIL ACTION NO. 99-20593
AMERICAN HOME PRODUCTS
2:16 MD 1203
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.
The Estate of Michael L. Jones ("Estate"), a
representative claimant under the Diet Drug Nationwide Class
Action Settlement Agreement (''Settlement Agreement") with Wyeth,
seeks benefits from the AHP Settlement Trust ("Trust") . 2
on the record developed in the show cause process, we must
determine whether the Estate has demonstrated a reasonable
medical basis to support its claim for Matrix Compensation
Benefits ("Matrix Benefits") . 3
Prior to March 11, 2002, Wyeth was known as American Home
In 2009, Pfizer, Inc. acquired Wyeth.
Jan E. Jones, the spouse of Michael L. Jones ("Mr. Jones"),
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 Diet Drug
(continued ... )
To seek Matrix Benefits, a representative claimant 4
must first submit a completed Green Form to the Trust.
Form consists of three parts.
The representative claimant
completes Part I of the Green Form.
Part II is completed by an
attesting physician, who must answer a series of questions
concerning the Diet Drug Recipient's medical conditions that
correlate to the Matrix criteria set forth in the Settlement
Finally, if the representative claimant is
represented by an attorney, the attorney must complete Part III.
In June, 2012, Michael L. Jones, Jr., the independent
executor of the Estate, submitted a completed Green Form to the
Trust signed by the attesting physician, Robert L. Rosenthal,
Based on an echocardiogram dated May 23, 2002,
( ... continued)
Recipients 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 the Diet Drug Recipient's valvular heart
See Settlement Agreement §§ IV.B.2.b. &
Matrix A-1 describes the compensation
available to representative claimants where the Diet Drug
Recipients were diagnosed with serious VHD, they took the drugs
for 61 days or longer, and they did not have any of the
alternative causes of VHD that made the B matrices applicable.
In contrast, Matrix B-1 outlines the compensation available to
representative claimants where the Diet Drug Recipients were
registered as having only mild mitral regurgitation by the close
of the Screening Period, they took the drugs for 60 days or less,
or they were diagnosed with conditions that would make it
difficult for them to prove that their VHD was caused solely by
the use of these Diet Drugs.
Under the Settlement Agreement, representative claimants
include estates, administrators or other legal representatives,
heirs, or beneficiaries.
See Settlement Agreement § II.B.
Dr. Rosenthal attested in Part II of the Green Form that
Mr. Jones suffered from moderate mitral regurgitation and that he
died as a result of a condition caused by VHD or valvular
repair/replacement surgery. 5
Based on such findings, the Estate
would be entitled to Matrix A-1, Level V benefits 6 in the amount
of $1,078,215. 7
In the report of the echocardiogram dated May 23, 2012,
the reviewing cardiologist, George G. Miller, M.D., F.A.C.C.,
stated that Mr. Jones had moderate mitral regurgitation, which he
measured at 21%.
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
Dr. Rosenthal also attested that Mr. Jones had surgery to
repair or replace the aortic and/or mitral valve(s) following the
use of Pondimin® and/or Redux™ and that he suffered from an
abnormal left atrial dimension, New York Heart Association
Functional Class IV symptoms, and a left ventricular ejection
fraction < 40% at any time six months or later after valvular
repair or replacement surgery.
These conditions are not at issue
in this claim.
Under the Settlement Agreement, a representative claimant is
entitled to Level V benefits if the Diet Drug Recipient suffered
"[d]eath resulting from a condition caused by valvular heart
disease or valvular repair/replacement surgery which occurred
post-Pondimin® and/or Redux™ use supported by a statement from an
attending Board-Certified Cardiothoracic Surgeon or BoardCertif ied Cardiologist, supported by medical records .... "See
Settlement Agreement § IV.B.2.c. (5) (c).
7. Mr. Jones previously received Matrix B-1, Level III benefits
in the amount of $146,733. According to the Trust, if entitled
to Matrix A-1, Level V benefits, the Estate would be entitled to
Matrix Benefits in the amount of $1,224,948.
The amount at
issue, therefore, is the difference between the Matrix B-1,
Level III benefits already paid and the amount of Matrix A-1,
Level V benefits.
See Settlement Agreement § IV.C.3.
is equal to or greater than 20% of the Left Atrial Area ("LAA").
See Settlement Agreement § I.22.
In August, 2012, the Trust forwarded the claim for
review by Noyan Gokce, M.D., F.A.C.C., F.A.S.E., one of its
In audit, Dr. Gokce concluded that there
was no reasonable medical basis for finding that the May 23, 2002
echocardiogram demonstrated moderate mitral regurgitation.
Dr. Gokce explained, "In my opinion, using the Singh criteria,
[mitral regurgitation] is mild.
My tracings at most demonstrated
a mitral RJA/LAA of 5.02/36.5 = 14% in the apical views,
consistent with mild [mitral regurgitation] ." 8
Dr. Gokce also
observed, "This finding is also in agreement with the report by
[Jeffrey S. Fierstein, M.D., F.A.C.C.] who calculated a ratio of
The Settlement Agreement requires the payment of
reduced Matrix Benefits when a Diet Drug Recipient is diagnosed
Under the Settlement Agreement, mild mitral regurgitation is
defined as "(1) either the RJA/LAA ratio is more than five
percent (5%) or the mitral regurgitant jet height is greater than
1 cm from the valve orifice, and (2) the RJA/LAA ratio is less
than twenty percent (20%)." Id.§ I.38.
In connection with the earlier claim for which Mr. Jones
received Matrix B-1, Level III benefits, Dr. Fierstein reviewed
the May 23, 2002 echocardiogram.
In a letter dated
April 25, 2004, Dr. Fierstein stated that the echocardiogram
demonstrated mild mitral regurgitation with an RJA/LAA ratio of
Dr. Fierstein explained, in pertinent part, "I utilized the
Singh method to measure these jets and the left atrial area.
These jets exist in more than one frame, seen in real time, and
confirmed by [Continuous Wave] Doppler, and they are
appropriately and tightly traced personally by me."
with mild mitral regurgitation by an echocardiogram that was
performed between the commencement of Diet Drug use and the end
of the Screening Period. 10
See id. § IV.B.2.d. (2) (a).
Trust does not contest the Estate's entitlement to Level V
benefits, the only issue before us is whether the Estate is
entitled to payment on Matrix A-1 or Matrix B-1.
Based on Dr. Gokce's finding that Mr. Jones had only
mild mitral regurgitation between the commencement of Diet Drug
use and the end of the Screening Period, the Trust issued a
post-audit determination that the Estate was entitled only to
Matrix B-1 benefits.
Pursuant to the Rules for the Audit of
Matrix Compensation Claims ("Audit Rules"), the Estate contested
this adverse determination.
In contest, the Estate argued that
the auditing cardiologist's calculation was ''flawed" because he
ignored the maximum regurgitant jet and instead "selected
measurements for the RJA and LAA that result in a skewed and
artificially low RJA/LAA ratio."
In support, the Estate
10. The Screening Period ended on January 3, 2003 for
echocardiograms performed outside of the Trust's Screening
Program and on July 3, 2003 for echocardiograms performed in the
Trust's Screening Program.
See id. § I.49.
11. 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 the
submitted a declaration from Dr. Rosenthal, who stated, in
On the apical 4 chamber view there are
multiple jets displayed which by the Singh
method of visual assessment fill 20% or
greater of the simultaneously displayed left
The one jet outlined in the
4 chamber view at 7:54:09 also fills more
than 20% of the left atrium ....
On the apical 2 chamber view at 7:55:36
there is a jet outlined measuring 8.35 cm.
sq. which by the Singh method of visual
assessment fills 20% or greater of the
simultaneously displayed left atrium....
auditing cardiologist has chosen to ignore
this jet which if used in the calculation he
provides would yield an RJA/LAA ratio of
22.87% (8.35 cm. sq./ 36.5 cm. sq.).
Instead, the auditing cardiologist chose to
use an inferior jet which is not the maximum
Furthermore, the LAA of 36.5 cm. sq. is
found in the 4 chamber view.
The LAA in the
2 chamber view is smaller than the LAA in the
4 chamber view.
Thus, if the auditing
cardiologist uses the appropriate LAA from
the 2 chamber view, the RJA/LAA ratio is
greater than 22.87%.
Dr. Rosenthal attached two still frame images from the
echocardiogram that purportedly demonstrated moderate mitral
In his declaration, Dr. Rosenthal also stated that "current
echocardiography guidelines and best practices recommend the use
of additional echocardiographic methods to determine the severity
of mitral regurgitation, including determination of vena
contracta width." According to Dr. Rosenthal, the vena contracta
width supports the conclusion that there is a reasonable medical
basis for finding moderate mitral regurgitation.
Although not required to do so, the Trust forwarded the
claim to the auditing cardiologist for a second review.
Dr. Gokce submitted a declaration in which he again concluded
that there was no reasonable medical basis for the attesting
physician's finding that echocardiogram demonstrated moderate
Dr. Gokce stated, in relevant part:
Dr. Rosenthal reports an RJA/LAA ratio
of greater than 20%, based in part upon
his measurement of a smaller LAA in the
2 chamber view.
This LAA is smaller
than the measurement I made and used in
The LAA cited by
Dr. Rosenthal appears falsely small,
however, and results in an
underestimation of the true left atrial
dimension, and an inf lated RJA/LAA
My measurement of the LAA was
taken at end systole, and I measured the
RJA in the same 4-chamber view.
measurements were taken at a point in
the study when both the RJA and LAA are
representative of what is seen
throughout the study, and result in an
accurate RJA/LAA ratio. As I noted at
audit, Dr. Fierstein, who prepared a
report based upon his review of the
May 23, 2002 study, measured an even
larger LAA, at 40.47 cm 2 •
I would also
like to point out that at 7:56:25, the
LAA was measured as significantly
enlarged at 40.42 cm 2 in the 4-chamber
view as clearly displayed on the
echocardiogram at that specific time
Dr. Rosenthal also states that, when
evaluated using the vena contracta
("VC") method, mitral regurgitation on
the May 23, 2002 study falls into the
severe range, citing to frames in the
However, the mitral
regurgitation in this study is slightly
eccentric, which renders evaluation via
the VC method less accurate than under
The VC method is
not utilized as part of the audit
Regardless, Dr. Rosenthal
indicates that the VC measurement of 0.7
would "fall into the severe
regurgitation range", however it is
clear that [mitral regurgitation] is not
Further, applying Singh
criteria, mitral regurgitation is mild.
Dr. Fierstein's independent assessment
was in agreement with my audit finding
of mild [mitral regurgitation].
Both at 7:45:09 and 7:55:36, the mitral
"regurgitant jet" measurement is
overestimated in the echocardiogram
because the tracings erroneously
incorporate the flow convergence signal
that is located on the left ventricular
side of the mitral valve ... , which is
not part of the regurgitation signal
proximal to the valve plane into the
left atrial cavity, as described by the
Further, the borders
of the regurgitant jet are loosely
Real-time examination of the
mitral regurgitant jet in multiple views
in the apical 4-chamber and 2-chamber
images throughout the entire
[echocardiogram] study are most
consistent with mild [mitral
Parasternal short axis
views (at 7:52:21 per contest letter)
are not part of the standard [mitral
regurgitation] quantification assessment
and are misleading.
Accordingly, I affirm my findings at
audit, that there is no reasonable
medical basis for a finding that
Claimant had moderate mitral
Mitral regurgitation on
the May 23, 2002 study is only mild, and
there is no reasonable medical basis to
conclude that moderate mitral
regurgitation is present.
I also affirm
my finding that there is no reasonable
medical basis to conclude that Claimant
had greater than mild mitral
regurgitation in between commencement of
Diet Drug use and the close of the
The Trust then issued a final post-audit
determination, again determining that the Estate was entitled
only to Matrix B-1, Level V benefits.
The Estate disputed this
final determination 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 the Estate's claim should be paid.
March 12, 2013, we issued an Order to show cause and referred the
matter to the Special Master for further proceedings.
No. 9026 (Mar. 12, 2013).
Once the matter was referred to the Special Master, the
Trust submitted its statement of the case and supporting
The Estate then served a response upon the
The Trust submitted a reply on June 12, 2013,
and the Estate submitted a sur-reply on July 9, 2013.
Audit Rules, it is within the Special Master's discretion to
appoint a Technical Advisor 13 to review claims after the Trust
and the Estate have had the opportunity to develop the Show Cause
See Audit Rule 30.
The Special Master assigned a
Technical Advisor, Gary J. Vigilante, M.D., F.A.C.C., to review
13. 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
the documents submitted by the Trust and the Estate and to
prepare a report for the court.
The Show Cause Record and
Technical Advisor Report are now before the court for final
See id. Rule 35.
The issue presented for resolution of this claim is
whether the Estate has met its burden of proving that there is a
reasonable medical basis for finding that Mr. Jones suffered from
moderate or greater mitral regurgitation on an echocardiogram
performed between the commencement of Diet Drug use and the end
of the Screening Period.
See Audit Rule 24.
Ultimately, if we
determine that there is no reasonable medical basis for the
answer in the Green Form that is at issue, we must affirm the
Trust's final determination and may grant such other relief as
See id. Rule 38(a).
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.
In support of its claim, the Estate reasserts the
arguments it made during contest.
The Estate also argues that
there is a reasonable medical basis for the claim because:
(1) the opinion of the attesting physician is entitled to
(2) the attesting physician, Dr. Rosenthal, adequately
rebutted the findings of the auditing cardiologist; and (3) the
reviewing cardiologist, Dr. Miller, also agreed that the
May 23, 2002 echocardiogram demonstrated moderate mitral
In addition, the Estate submitted a supplemental
declaration from Dr. Rosenthal, in which he again opines that the
echocardiogram reveals the presence of moderate mitral
Dr. Rosenthal states, in pertinent part:
I re-reviewed the 5/23/02 echocardiogram
disc in light of Dr. Noyan Gokce's recent
declaration dated 2/19/13.
The LAA in the 2 chamber view is not
"falsely small," and the use of revised LAA
measurements of 40.47 cm sq and 40.42 cm sq
is inappropriate in this case.
measurements are not representative of the
LAA seen throughout the study.
initial report, Dr. Gokce chose to ignore the
8.35 cm sq jet present on the apical
2 chamber view at 7:55:36 which by the Singh
method fills 20% or greater of the
simultaneously displayed left atrium.
paragraph 11 of his declaration, Dr. Gokce
indicates that the LAA in the 2 chamber view
appears "falsely small" but offers no proof
that the LAA in any 2 chamber view on the
recording is larger.
Instead, Dr. Gokce
indicates he prefers to use the, in his
words, "significantly enlarged" left atrial
area in the 4 chamber view, which is not
appropriate, as this is not the same
2 chamber view in which the jet is
Dr. Gokce had initially reported
his measurement of 4 chamber LAA at 36.5 cm
sq and now revises that to be perhaps 40.42
or 40.47 cm sq. Furthermore, Dr. Gokce admits
these measurements are "significantly
In fact, a LAA of 40 cm sq is
classified as "severely enlarged" with a
normal LAA being less than 20 cm sq ....
instead of the appropriately measured left
atrial 2 chamber being "falsely small",
Dr. Gokce's measurement appears to be
Dr. Rosenthal also again asserts that methods other than the
Singh method confirm the presence of moderate mitral
The Settlement Agreement, however, requires the
use of the Singh method in determining the level of mitral
Settlement Agreement § I.22.
"falsely enormous" indicating the subject's
left atrium is more than twice normal size.
Of course, substituting a more normal left
atrial area as seen in the appropriate
2 chamber view lowers the denominator and
makes the ratio of the jet greater.
Regardless, the jet of 8.35 cm sq. is greater
than 20% of all of Dr. Gokce's left atrial
measurements, however inappropriate and
enlarged they may be.
Dr. Gokce does not continue to assert that
the RJA measures 5.02 cm sq.
In contrast, I
reaffirm the sizes of the jets that I
previously identified, and I affirmatively
state that these jets are representative of
other moderate [mitral regurgitant] jets,
which I observed on the still frames and in
Dr. Gokce also indicates that the jets
are "loosely traced" which is a subjective
opinion for which no factual evidence is
I believe that the jets are
Dr. Gokce indicates
that the jet measurements are overestimated
because the tracings incorporate the flow
convergence signal that is located on the
left ventricular side of the mitral valve.
do not believe that to be the case, but that
is an argument which Dr. Gokce needs to be
cautious in advancing because a flow
convergence jet of any size would be further
evidence of moderate to severe mitral
[T] he "Flow Convergence
Method" is a quantitative tool for measuring
the severity of mitral regurgitation with
increasing flow convergence indicating more
severe mitral regurgitation.
standard and accepted PISA formula method, a
flow convergence jet with a radius of only
.71 cm (enough to reduce the Jones measured
jet size by 10%) at this Nyquist limit of 51
cm/sec. would give an ERO of 0.3 cm. sq.
indicating moderate to severe mitral
In my opinion, any
argument offered that a significant flow
convergence jet is present is further
evidence that the mitral regurgitation jet is
moderate or even severe.
Finally, the Estate asserts that the Settlement Agreement
"guarantees supplemental payments to class members whose
conditions deteriorate to certain levels."
In response, the Trust argues that the Estate has not
established a reasonable medical basis for Dr. Rosenthal's
representation that Mr. Jones had moderate mitral regurgitation
between the commencement of Diet Drug use and the end of the
Screening Period and that the reasonable medical basis standard
does not require that deference be given to the findings of the
In addition, the Trust contends that the
auditing cardiologist is not required to rely on the maximum jet
of mitral regurgitation if that jet is not representative of the
regurgitation through the echocardiogram.
The Technical Advisor, Dr. Vigilante, reviewed the
May 23, 2002 echocardiogram and concluded that there was no
reasonable medical basis for finding that it demonstrated
moderate or greater mitral regurgitation.
Dr. Vigilante stated, in pertinent part:
I reviewed the videotape and DVD of the
Claimant's May 23, 2002 echocardiogram ....
All of the usual echocardiographic views were
This study was limited due to poor
ultrasound transmission from obesity.
However, the Nyquist limit was appropriately
set at 50 cm per second at a depth of 20 cm
in the parasternal views and 51 cm per second
at a depth of 18 cm in the apical views.
There was somewhat increased color artifact
although the study was diagnostic .
.... Visually, mild mitral regurgitation
appeared to be present.
I digitized the
cardiac cycles in the apical four and two
chamber views in which the mitral regurgitant
jet was best appreciated.
I then traced the
representative RJAs as well as the LAA in the
apical four and two chamber views.
apical four chamber view, the largest
representative RJA was 5.1 cm2.
The LAA was
Therefore, the largest
representative RJA/LAA ratio was 13.3%
qualifying for mild mitral regurgitation.
The largest representative RJA in the apical
two chamber view was 6.1 cm2.
The LAA in the
apical two chamber view was 33.9 cm2.
Therefore, the largest representative RJA/LAA
ratio was 18.0% diagnostic of mild mitral
The sonographer planimetered
supposed RJAs of 5.86 cm2 in the apical four
chamber view and 8.35 cm in the apical two
However, these determinations
were inaccurate as they contained low
velocity and non-mitral regurgitant flow.
The sonographer also obtained a supposed LAA
of 40.42 cm2 in the apical four chamber view.
However, this tracing occurred outside the
inter-atrial septum and partly within the
right atrium and was inaccurate.
sonographer did not demonstrate an LAA
determination in the apical two chamber view.
I paid particular attention to the time
frames quoted by Dr. Rosenthal in his
Declarations. These time frames demonstrated
the same inaccurate RJA determinations by the
I did not evaluate the vena
contracta in this study as this determination
is not pertinent to the Settlement Agreement.
[T]here is no reasonable medical basis
for the finding of moderate or greater mitral
regurgitation based on the Claimant's
echocardiogram of May 23, 2002.
this study demonstrated mild mitral
regurgitation with comments as above.
echocardiographer could not reasonably
conclude that moderate mitral regurgitation
was present on this study even taking into
account the issue of inter-reader variability
when appropriate measurements are taken of
the RJA and LAA in the apical four and two
In response to the Technical Advisor Report, the Estate
argues that the Technical Advisor failed to apply the reasonable
medical basis standard and "failed to utilize normal clinical
judgment and accepted medical standards."
The Estate also
contends that the Technical Advisor did not provide documentary
proof that the level of mitral regurgitation was less than
moderate or that the sonographer's measurements on the
echocardiogram were unreasonable.
Finally, the Estate argues
that the Technical Advisor's and the auditing cardiologist's
findings were inconsistent and arbitrary.
After reviewing the entire Show Cause Record, we find
the Estate's arguments are without merit.
Agreement requires that a claim for Level V Matrix Benefits be
reduced to the B Matrix if the Diet Drug Recipient had mild
mitral regurgitation diagnosed by an echocardiogram performed
between the commencement of Diet Drug use and the end of the
Settlement Agreement § IV.B.2.d. (2) (a).
Claimant contends that the declarations of
Dr. Rosenthal establish a reasonable medical basis for finding
that Mr. Jones suffered from moderate mitral regurgitation before
the end of the Screening Period.
We are required
to apply the standards delineated in the Settlement Agreement and
the Audit Policies and Procedures.
The context of these two
documents leads us to interpret the reasonable medical basis
standard as more stringent than the Estate 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
failing to have a Board Certified
Cardiologist properly supervise and interpret the echocardiogram;
(3) failing to examine the regurgitant jet throughout a portion
(4) over-manipulating echocardiogram settings;
(5) setting 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) 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) .
Dr. Gokce reviewed the May 23, 2002
echocardiogram and determined that it demonstrated only mild
mitral regurgitation. 15
Although Dr. Rosenthal identified two
regurgitant jets that he contends support his opinion, Dr. Gokce
reviewed these jets and determined they were "overestimated in
the echocardiogram because the tracings erroneously incorporate
the flow convergence signal that is located on the left
ventricular side of the mitral valve ... , which is not part of
the regurgitation signal proximal to the valve plane into the
left atrial cavity, as described by the Singh methodology."
Dr. Gokce noted that this finding is consistent with that of
Dr. Fierstein who previously reviewed the echocardiogram for
claimant. We cannot, as the Estate suggests, simply ignore the
opinion of one of its own physicians in determining whether there
is a reasonable medical basis for the claim.
In addition, Dr. Vigilante reviewed the May 23, 2002
echocardiogram and concluded that it was representative of only
mild mitral regurgitation.
Specifically, Dr. Vigilante observed
that the sonographer's "determinations were inaccurate as they
contained low velocity flow and non-mitral regurgitant flow."
With respect to the frames identified by Dr. Rosenthal as
demonstrative of moderate mitral regurgitation, Dr. Vigilante
observed that "[t]hese time frames demonstrated the same
inaccurate RJA determinations by the sonographer."
unacceptable practices cannot provide a reasonable medical basis
for the resulting Green Form representation of moderate mitral
We also disagree with claimant's argument that the
auditing cardiologist erred by not relying on the maximum jet
rather than a representative jet.
We previously have held that
"[f]or a reasonable medical basis to exist, a claimant must
establish that the findings of the requisite level of mitral
regurgitation are representative of the level of regurgitation
throughout the echocardiogram."
Mem. in Supp. of PTO No. 6997,
at 11 (Feb.26, 2007); see also In re Diet Drugs
(Phentermine/Fenfluramine/Dexfenfluramine) Prods. Liab. Litig.,
543 F.3d 179, 187 (3d Cir. 2008).
"To conclude otherwise would
allow claimants who do not have moderate or greater mitral
For this reason as well, we reject the Estate's argument
that the attesting physician's representation is entitled to
regurgitation to receive Matrix Benefits, which would be contrary
to the intent of the Settlement Agreement."
See Mem. in Supp. of
PTO No. 6997, at 11.
Finally, we reject the Estate's assertion that the
Settlement Agreement "guarantees" progression benefits on
As noted above, the Settlement Agreement specifically
requires that a claim for benefits based on damage to the mitral
valve be reduced to the B Matrix if the Diet Drug Recipient had
"Mild Mitral Regurgitation by an Echocardiogram performed between
the commencement of Diet Drug use and the end of the Screening
Settlement Agreement§ IV.B.2.d. (2) (a).
Estate has failed to establish a reasonable medical basis for
finding that Mr. Jones was not diagnosed with mild mitral
regurgitation, the Settlement Agreement requires the claim for
Level V benefits to be reduced to the B Matrix.
While the Estate contends that the Settlement Agreement
guarantees payment on Matrix A, it has provided no support for
The Estate merely argues that it has "the right
to receive additional benefits if [the Diet Drug Recipient's]
condition worsens," which is exactly what has happened here.
Mr. Jones was previously paid Matrix B, Level III benefits. 17
The Estate subsequently submitted the present claim, and the
Trust determined that the Estate qualified for Matrix B, Level V
This claim also was reduced to the B Matrix due to the
presence of mild mitral regurgitation prior to the close of the
Nothing in the Settlement Agreement requires a
supplemental claim for benefits to be paid on the A Matrix when
an applicable reduction factor is present.
Therefore, we will affirm the Trust's denial of the
Estate's claim for Matrix A benefits, and the related derivative
claim submitted by Mr. Jones's spouse.
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