BROWN, et al v. AMERICAN HOME PROD, et al
Filing
4875
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9132 RE: CLAIMANT JOHN V. DAVIS. SIGNED BY HONORABLE HARVEY BARTLE, III ON 8/16/2013; 8/16/2013 ENTERED AND COPIES MAILED AND E-MAILED TO LIAISON COUNSEL. (SEE PAPER # 110092 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 NO.
qI3;;)..
August
Bartle, J.
John V. Davis ( 11 Mr. Davis 11 or
11
I b, 2 013
claimant 11 ) , a class
member under the Diet Drug Nationwide Class Action Settlement
Agreement ( 11 Settlement Agreement 11 ) with Wyeth,
from the AHP Settlement Trust ( 11 Trust 11 ) .
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
his claim for Matrix Compensation Benefits ( 11 Matrix Benefits 11 )
•
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 11 A 11 and Matrix 11 B 11 ) , 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 ( 11 VHD 11 ) . 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 July, 2010, claimant submitted a completed Green
Form to the Trust signed by his attesting physician,
Manoj R. Muttreja, M.D.
April 21, 2003,
3
Based on an echocardiogram dated
Dr. Muttreja attested in Part II of claimant's
Green Form that Mr. Davis suffered from moderate mitral
regurgitation, an abnormal left atrial dimension, and ventricular
fibrillation or sustained ventricular tachycardia which results
in hemodynamic compromise.
Based on such findings, claimant
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 cau~ed solely by the use of
these Diet Drugs.
3.
Because claimant's April 21, 2003 echocardiogram was
performed after the end of the Screening Period, claimant relied
on an echocardiogram dated June 14, 2002 to establish his
eligibility for Matrix Benefits.
-2-
would be entitled to Matrix A-1, Level V benefits in the amount
of $1,059,643. 4
In the report of claimant's April 21, 2003
echocardiogram, the reviewing cardiologist, James W. Smith, M.D.,
stated,
"The mitral valve shows calcification of the mitral
annulus with mild systolic anterior motion of the anterior
leaflet."
In addition, in the report of claimant's June 14, 2002
echocardiogram, the reviewing cardiologist, David Liang, M.D.,
stated,
"There is mild mitral annular calcification."
Under the
Settlement Agreement, the presence of mitral annular
calcification requires the payment of reduced Matrix Benefits.
See Settlement Agreement
§
IV.B.2.d. (2) (c)ii)d).
Dr. Muttreja,
however, attested in claimant's Green Form that Mr. Davis did not
suffer from mitral annular calcification.
In September, 2010, the Trust forwarded the claim for
review by Waleed N. Irani, M.D., F.A.C.C., one of its auditing
cardiologists.
In audit, Dr. Irani determined that there was no
reasonable medical basis for the attesting physician's
representation that claimant had moderate mitral regurgitation
based on claimant's April 21, 2003 echocardiogram.
Specifically,
4. Under the Settlement Agreement, a claimant is entitled to
Level V benefits if he or she qualifies for Level II benefits and
suffers from ventricular fibrillation or sustained ventricular
tachycardia which results in hemodynamic compromise.
See
Settlement Agreement § IV.B.2.C. (5) (d). A claimant qualifies for
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 id. § IV.B.2.c. (2) (b). An abnormal left atrial dimension is
one of the factors needed to qualify for Level II benefits.
-3-
Dr. Irani explained,
11
0nly mild [mitral regurgitation] seen on
study with ratio of approximately 10-15%.
11
Dr. Irani also
concluded that there was a reasonable medical basis for the Green
Form representation 5 that claimant did have mitral annular
calcification based on claimant's June 14, 2002 echocardiogram
because
11
mild posterior [mitral annular calcification]
present.
[was]
116
Based on Dr. Irani's finding that claimant's
April 21, 2003 echocardiogram demonstrated only mild mitral
regurgitation, the Trust issued a post-audit determination
denying the claim.
Pursuant to the Rules for the Audit of Matrix
Compensation Claims ( 11 Audit Rules 11 ) , claimant contested this
adverse determination. 7
In contest, Mr. Davis argued that the
auditing cardiologist should have determined whether claimant's
5. As noted, Dr. Muttreja did not attest that claimant suffered
from mitral annular calcification.
6.
In addition, Dr. Irani found that claimant's June 14, 2002
echocardiogram demonstrated moderate mitral regurgitation and
agreed with Dr. Muttreja•s representation that claimant suffered
from ventricular fibrillation or sustained ventricular
tachycardia which results in hemodynamic compromise because
11
[patient] had [ventricular tachycardia] which deteriorated to
[ventricular fibrillation] requiring defibrillation in the
[emergency room] . 11
7.
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 ( 11 PT0 11 ) 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 claim
of Mr. Davis.
-4-
June 14, 2002 echocardiogram demonstrated an abnormal left atrial
dimension.
According to claimant, he may rely on his
June 14, 2002 echocardiogram to satisfy the Matrix Level II
prerequisite to his claim for Matrix Level V benefits based on
ventricular fibrillation or sustained ventricular tachycardia
which results in hemodynamic compromise, irrespective of the
results of the audit of his April 21, 2003 echocardiogram.
Claimant also contended that the auditing cardiologist's finding
of mitral annular calcification was not supported by the
evidence.
Although not required to do so, the Trust forwarded the
claim to the auditing cardiologist for a second review.
Dr. Irani submitted a declaration in which he concluded that
there was no reasonable medical basis for finding that Mr. Davis
did not have mitral annular calcification.
In particular,
Dr. Irani explained:
11.
At Contest, I was also asked to
determine whether mitral annular
calcification is present on the
April 21, 2003 echocardiogram of
attestation, the June 14, 2002
eligibility echocardiogram, and
echocardiogram studies dated
November 30, 2001, May 28, 2002, and
September 20, 2002.
12.
Upon review of the Ap~il 21, 2003
echocardiogram study at Contest, I
observed posterior miiral annular
calcification that is mild, but present,
in the PLAX images.
rhere is no
reasonable medical basis to conclude
that mitral annular calcification is not
present on this study.
-5-
13.
Mitral annular calcification is also
present on the June 14, 2002
echocardiogram study, as I noted at
audit. There is no reasonable medical
basis to conclude that mitral annular
calcification is not present on this
study.
Dr. Irani also reviewed claimant's June 14, 2002 echocardiogram
and determined that, in addition to moderate mitral
regurgitation,
"it would not be unreasonable to conclude that
left atrial enlargement is present on that study."
The Trust then issued a final post-audit determination,
again denying the claim.
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 his 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 , 2 0 11 ) .
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 July 14, 2011, and
claimant submitted a sur-reply on August 2, 2011.
Under the
Audit Rules, it is within the Special Master's discretion to
-6-
appoint a Technical Advisor 8 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
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 his burden of proving that there is a
reasonable medical basis for his claim.
See id. Rule 24.
Ultimately, if we determine that there is no reasonable medical
basis for the claim, we must affirm the Trust's final
determination and may grant such other relief as deemed
appropriate.
See id. Rule 38(a).
If, on the other hand, we
determine that there is a reasonable medical basis for the claim,
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 his claim, Mr. Davis argues that he is
entitled to Level V Matrix Benefits because the Trust concedes
both that his June 14, 2002 echocardiogram qualified him for
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
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-
Level II benefits and that he suffered from ventricular
fibrillation or sustained ventricular tachycardia which resulted
in hemodynamic compromise on December 9, 2004.
According to
Mr. Davis, whether his April 21, 2003 echocardiogram qualifies
him for Level II benefits is irrelevant because the plain
language of the Settlement Agreement only requires that he
qualify for benefits at Matrix Level II at the time he suffers
ventricular fibrillation or sustained ventricular tachycardia
which results in hemodynamic compromise.
Claimant contends this
interpretation is consistent with our decisions in PTO Nos. 3193
and 8595 and Section VI.C.1.d. of the Settlement Agreement, which
provides:
A claimant who qualifies for a particular
Matrix payment, by virtue of a properly
interpreted Echocardiogram showing the
required levels of regurgitation and/or
complicating factors, after exposure to
fenfluramine and/or dexfenfluramine, shall
not be disqualified from receiving that
Matrix payment in the event that a subsequent
Echocardiogram shows that the required levels
of regurgitation and/or complicating factors
are no longer present.
Claimant also asserts that the only relevant echocardiogram for
determining whether claimant has mitral annular calcification is
his June 14, 2002 echocardiogram and that there is a reasonable
medical basis for Dr. Muttreja•s representation that Mr. Davis
did not have mitral annular calcification based on that
echocardiogram.
In response, the Trust argues that Mr. Davis cannot
meet the requirements for Matrix Level V benefits because he did
-8-
not concurrently qualify for Matrix Level II benefits and suffer
ventricular fibrillation or sustained ventricular tachycardia
which resulted in hemodynamic compromise.
The Trust maintains
that his April 21, 2003 echocardiogram, the echocardiogram
performed immediately preceding his episode of ventricular
fibrillation or sustained ventricular tachycardia which resulted
in hemodynamic compromise, does not demonstrate Matrix Level II
qualifying conditions. The Trust further asserts that Section
VI.C.1.d. does not change this result because that section
pertains only to whether a claimant qualifies for certain Matrix
Benefits, not the presence or absence of the medical conditions
giving rise to the particular claim.
Finally, the Trust argues
that Mr. Davis did not establish a reasonable medical basis for
Dr. Muttreja's representation that claimant did not have mitral
annular calcification.
The Technical Advisor, Dr. Abramson, reviewed
claimant's echocardiograms and concluded that there was no
reasonable medical basis for Dr. Muttreja's representation that
Mr. Davis did not have mitral annular calcification.
Specifically, Dr. Abramson noted that each of claimant's
echocardiograms, dated November 30, 2001, May 28, 2002,
June 14, 2002, September 20, 2002, and April 21, 2003,
demonstrated mild mitral annular calcification.
-9-
Mr. Davis submitted a response to the Technical Advisor
Report but did not address Dr. Abramson's findings with respect
to mitral annular calcification. 9
After reviewing the entire Show Cause Record, we find
that claimant is entitled to Matrix B-1, Level V benefits.
Under
the Settlement Agreement, a claimant is entitled to Level V
Matrix Benefits if the following definition is met:
(d)
The individual otherwise qualifies for
payment at Matrix Level II, III, or IV
and suffers from ventricular
fibrillation or sustained ventricular
tachycardia which results in hemodynamic
compromise.
Settlement Agreement
§
IV.B.2.c. (5) (d).
In the present case, the Trust does not contest that
Mr. Davis qualified for Level II Matrix Benefits based on his
June 14, 2002 echocardiogram or that Mr. Davis suffered from
ventricular fibrillation or sustained tachycardia which resulted
in hemodynamic compromise on December 9, 2004.
The Trust,
however, argues that Mr. Davis cannot meet the requirements for
Matrix Level V benefits as set forth in PTO No. 3193 because his
9.
Claimant also included with his response to the Technical
Advisor Report a supplemental declaration of Dr. Muttreja.
Pursuant to Audit Rule 34, the Special Master advised Mr. Davis
that Dr. Muttreja's supplemental declaration could not become
part of the Show Cause Record.
Thereafter, claimant filed a
motion to have this additional report included in the Show Cause
Record. As we previously have stated, pursuant to Audit Rule 34,
there is no procedure by which a supplemental declaration such as
Dr. Muttreja's can become part of the Show Cause Record.
See
Mem. in Supp. of PTO No. 9041, at 9-10 n.11 (Apr. 5, 2013).
In
any event, given our disposition, Dr. Muttreja's supplemental
declaration is irrelevant to resolution of this claim.
Accordingly, we will deny the motion as moot.
-10-
April 21, 2003 echocardiogram does not demonstrate that he
qualifies for payment at Matrix Level II, III, or IV.
In PTO No. 3193, we rejected a claim for Matrix Level V
benefits because claimant's episode of "ventricular fibrillation
occurred and ended before the existence of factors qualifying her
for Matrix Level II payments."
at 4 (Jan. 7, 2004).
Mem. in Supp. of. PTO No. 3193,
In PTO No. 8595, we found that claimant
demonstrated it was entitled to Level V benefits where the Diet
Drug Recipient qualified for Level II Matrix Benefits based on an
echocardiogram performed in March, 2002 but did not suffer an
episode of ventricular fibrillation or ventricular tachycardia
which resulted in sustained hemodynamic compromise until
August, 2003.
Mem. in Supp. of PTO No. 8595, at 2-3, 12-15
(Feb. 3, 2 011) .
As did the Diet Drug Recipient in PTO No. 8595,
Mr. Davis qualified for Matrix Level II benefits based on an
echocardiogram performed prior to his episode of ventricular
fibrillation.
Specifically, Mr. Davis qualifies for Level II
benefits based on his June 14, 2002 echocardiogram and he
subsequently suffered an episode of ventricular fibrillation on
December 9, 2004.
The fact that claimant's April 21, 2003
echocardiogram does not qualify him for Level II benefits is thus
irrelevant.
Accordingly, he has satisfied the criteria for Level
V benefits.
We must, however, still determine whether claimant
should be paid on Matrix A-1 or Matrix B-1.
-11-
As noted previously,
the Settlement Agreement provides that the presence of mitral
annular calcification requires the payment of reduced Matrix
Benefits.
See Settlement Agreement
§
IV.B.2.d. (2) (c) (ii)d)
The
auditing cardiologist reviewed claimant's medical records,
including his echocardiograms, and concluded that there was a
reasonable medical basis for representing that claimant had
mitral annular calcification.
Although claimant responded that
Dr. Irani did not consider claimant's June 14, 2002
echocardiogram, Dr. Irani submitted a supplemental declaration
wherein he confirmed that claimant's June 14, 2002 echocardiogram
in fact demonstrated mitral annular calcification. 10
In
addition, Dr. Abramson reviewed claimant's medical records,
including claimant's numerous echocardiograms, and concluded that
each one demonstrated mitral annular calcification.
Despite
submitting a response to the Technical Advisor Report, claimant
did not dispute Dr. Abramson's finding in this regard.
Thus,
claimant has not established a reasonable medical basis for
Dr. Muttreja's representation that claimant did not have mitral
annular calcification.
For the foregoing reasons, we conclude that claimant
has met his burden of proving that he is entitled to Level V
benefits but has not met his burden of proving that he is
10.
In any event, we reject claimant's contention that his
June 14, 2002 echocardiogram is the "relevant echocardiogram" for
purposes of determining whether the reduction factor of mitral
annular calcification applies.
See Mem. in Supp. of PTO
No. 8822, at 9-11 (Feb. 22, 2012), aff'd, No. 12-3138, 2013 WL
216619, at *2-3 (May 21, 2013).
-12-
entitled to Matrix A-1 benefits.
Therefore, we will affirm the
Trust's denial of the claim of Mr. Davis for Matrix A-1, Level V
benefits but will reverse the Trust's denial of the claim of
Mr. Davis for Matrix B-1, Level V benefits.
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