The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE: DIET DRUGS (PHENTERMINE/ )
FENFLURAMINE/DEXFENFLURAMINE) ) MDL NO. 1203
PRODUCTS LIABILITY LITIGATION )
)
)
THIS DOCUMENT RELATE TO: )
)
SHEILA BROWN, et al. )
) CIVIL ACTION NO. 99-20593
v. )
)
AMERICAN HOME PRODUCTS ) 2:16 MD 1203
CORPORATION )
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9534
Bartle, J. November 18, 2021
The Estate of Alice C. Petersen (“Estate”, a
representative class member under the Diet Drug Nationwide Class
Action Settlement Agreement (“Settlement Agreement”) with Wyeth,1
seeks benefits from the AHP Settlement Trust (“Trust”). Based
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”).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”).
(continued . . .)
To seek Matrix Benefits, a representative claimant3
must first submit a completed Green Form to the Trust. The
Green 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
Agreement. Finally, if the representative claimant is
represented by an attorney, the attorney must complete Part III.
In June, 2019, the Estate submitted a completed Green
Form to the Trust signed by the attesting physician, Michael
Mancina, M.D., F.A.C.C. Based on an echocardiogram dated
March 11, 2000, Dr. Mancina attested in Part II of the Green
Form that Ms. Petersen suffered from mid aortic regurgitation,
(continued . . .)
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 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. Under the Settlement Agreement, representative claimants
include estates, administrators or other legal representatives,
heirs, or beneficiaries. See Settlement Agreement § II.B.
moderate mitral regurgitation, mild or greater aortic
regurgitation and/or moderate or greater mitral regurgitation
with bacterial endocarditis,4 an abnormal left atrial dimension,
and ventricular fibrillation or sustained ventricular
tachycardia which results in hemodynamic compromise.
In February, 2020, the Estate submitted an amended
Part II of the Green Form in which Dr. Mancina attested that
Ms. Petersen also suffered death as a result of a condition
caused by VHD or valvular report/replacement surgery.5 Based on
such findings, claimant would be entitled to Matrix A-1, Level V
benefits,6 in the gross amount of $1,510,758.7
4. Dr. Mancina later explained that this response was mismarked
and that Ms. Petersen did not suffer from bacterial
endocarditis. This condition is therefore not at issue in this
claim.
5. As required by the Green Form, the Estate included a
statement of Ms. Petersen’s attending board-certified
cardiologist, Ghiyath Tabbal, M.D., F.H.R.S., setting forth his
opinion that Ms. Petersen’s death resulted from a condition
caused by VHD and/or valvular repair/replacement surgery.
6. Under the Settlement Agreement, a claimant is entitled to
Level V benefits if, among other things, (1) the Diet Drug
Recipient suffers death resulting from a condition caused by VHD
or valvular repair/replacement surgery, see Settlement Agreement
§ IV.B.2.c.(5)(c); or (2) the Diet Drug Recipient qualifies for
Level II benefits and suffers from ventricular fibrillation or
sustained tachycardia which result in hemodynamic compromise,
see id. § IV.B.2.c.(5)(d). A claimant is entitled to Level II
benefits for damage to the mitral valve if the Diet Drug
Recipient is diagnosed with moderate or severe mitral
regurgitation and one of five complicating factors delineated in
the Settlement Agreement, including an abnormal left atrial
(continued . . .)
In the report of Ms. Petersen’s echocardiogram, the
reviewing cardiologist, Lawrence S. Cohen, M.D., stated that
claimant had “mild mitral regurgitation with 28% regurgitant jet
area/left atrial area ratio.” 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 § I.22.
In October, 2019, the Trust forwarded the claim for
review by Zuyue Wang, M.D., one of its auditing cardiologists.
In audit, Dr. Wang concluded that there was no reasonable
medical basis for finding that claimant had moderate mitral
regurgitation. In April, 2020, the Trust forwarded the amended
claim for review by Dr. Wang. In audit, Dr. Wang concluded that
there was no reasonable medical basis for finding that
(continued . . .)
dimension. See id. § IV.B.2.c.(2)(b)ii). As the Trust does not
contest that Ms. Petersen had an abnormal left atrial dimension
or that she suffered from ventricular fibrillation or sustained
tachycardia which result in hemodynamic compromise, the only
conditions at issue in this claim are the level of her mitral
regurgitation and whether she suffered death as a result of a
condition caused by VHD or valvular repair/replacement surgery.
7. Because Ms. Petersen previously was paid Matrix A-1, Level
II benefits, if the Estate is entitled to A-1, Level V benefits,
it only would be entitled to the difference between the Matrix
A-1, Level II benefits already paid and the amount of Matrix
A-1, Level V benefits.
Ms. Petersen suffered death resulting from a condition caused by
VHD or valvular repair/replacement surgery. Dr. Wang explained,
The death was not caused by [VHD]
because the echo on 8/1/17 prior to death
showed normal left ventricular size, normal
systolic/diastolic function, normal right
ventricular function, only mild mitral
regurgitation, no aortic regurgitation and
no pulmonary hypertension. There was no
evidence of structural and hemodynamic
impact from mild mitral regurgitation. Mild
mitral regurgitation and/or aortic
regurgitation does not cause atrial and
ventricular fibrillation. Long-standing
SEVERE mitral and/or aortic regurgitation
can potentially cause left ventricular (LV)
dilation and dysfunction, which subsequently
results in ventricular or atrial
fibrillation. [Patient] had mild mild [sic]
regurgitation and normal LV size and
function.
Based on the auditing cardiologist’s findings, the
Trust issued a post-audit determination that the Estate was not
entitled to Matrix A-1, Level V benefits. Pursuant to the Rules
for the Audit of Matrix Compensation Claims (“Audit Rules”),
claimant contested this adverse determination.8 In contest, the
Estate argued that there was a reasonable basis for finding that
8. 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 Estate’s claim.
Ms. Petersen suffered moderate mitral regurgitation. In
support, the Estate submitted a statement from Dr. Mancina in
which he said, “Three well defined mitral regurgitant jets are
seen originating from the mitral leaflet that have an RJA
exceeding twenty percent.” Dr. Mancina included pictures of the
three jets as further support. In addition, the Estate argued
that there was a reasonable basis for finding that Ms. Petersen
suffered death as a result of a condition caused by VHD or
valvular repair/replacement surgery. In support, the Estate
submitted a statement by Dr. Tabbal in which he said that the
auditing cardiologist’s definition was too narrow and failed to
take into consideration “individual bio-variability.”
Dr. Tabbal included several medical journals and abstracts in
support of his position. Dr. Tabbal also explained that he
ruled out other causes of Ms. Petersen’s arrhythmias.
Although not required to do so, the Trust forwarded
the claim to the auditing cardiologist for a second review.
Dr. Wang submitted a declaration in which she again concluded
that there was no reasonable medical basis for finding that
Ms. Petersen had moderate mitral regurgitation or that she
suffered death as a result of a condition caused by VHD or
valvular repair/replacement surgery. Specifically, Dr. Wang
stated:
11. As requested by the Trust, I
again reviewed the Claim as well as
Claimant’s Contest Materials.
12. Based on my review, I confirm
my finding at audit that there is no
reasonable medical basis for the Attesting
Physician’s finding that Claimant had
moderate mitral regurgitation. Upon review
in contest, I again reviewed the entire
March 11, 2000 [echocardiogram of
attestation], identified a regurgitant jet
representative of the mitral regurgitation
seen in real time. The mitral valve
regurgitation is clearly only mild with an
RJA/LAA ratio clearly less than the 20%
threshold to find moderate mitral
regurgitation. I also confirm my findings
that Ms. Peterson’s [sic] left ventricular
size was normal with supernormal EF of 74%
and confirm my opinion that her mild mitral
and aortic regurgitation was not the cause
for the ventricular tachycardia which
resulted in her death.
13. This patient presented to the
Emergency Room two days after atrial flutter
ablation with complaints of shortness of
breath. No echocardiogram was performed at
that time and she was treated for
hypervolemia with diuretics. She returned
to the ER three weeks later, on August 21,
2017 with hypotension/ventricular
tachycardia (VT) and passed away after
cardioversion for VT. There was no sign of
CHF based on the chest X-ray and ER note of
August 21,2017.
The Trust then issued a final post-audit determination
again determining that the Estate was not entitled to Matrix A-
1, Level V benefits. 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 the Estate’s claim should be paid. On April 20, 2021, the
court issued an Order to show cause and referred the matter to
the Special Master for further proceedings. See PTO No. 9531
(Apr. 20, 2021).
Once the matter was referred to the Special Master,
the Trust submitted its statement of the case and supporting
documentation. Claimant then served a response upon the Special
Master. The Trust submitted a reply on June 16, 2021. Under
the Audit Rules, it is within the Special Master’s discretion to
appoint a Technical Advisor9 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, Gary J. Vigilante, M.D., F.A.C.C., to review
the documents submitted by the Trust and claimant and to prepare
a report for the court. The Show Cause Record and Technical
9. 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.
Advisor Report are now before the court for final determination.
See id. Rule 35.
The issues presented for resolution of this claim are
whether claimant has met its burden of proving that there is a
reasonable medical basis for finding that Ms. Petersen had
moderate mitral regurgitation and that Ms. Petersen suffered
death as a result of a condition caused by VHD or valvular
report/replacement surgery. See id. Rule 24. Ultimately, if
there is no reasonable medical basis for either of these
findings, the court must confirm the Trust’s final determination
and may grant such other relief as deemed appropriate. See id.
Rule 38(a). If, on the other hand, there is a reasonable
medical basis for one of these findings, the court 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, the Estate repeats the
arguments that it made in contest. In addition, the Estate
contends that the reasonable medical basis standard “is not a
competition between different medical diagnoses, but rather, is
a relatively liberal standard where differing medical opinions
may all fall within the scope of a reasonable medical basis.”
Claimant contends that Dr. Tabbal’s statement “is truly relevant
here,” because whether Ms. Petersen died as a result of a
condition caused by VHD or valvular report/replacement surgery
“requires a clinical, ‘hands on’ diagnosis of those underlying
medical factors that contributed to the condition that resulted
in death.”
In response, the Trust argues that the Settlement
Agreement requires denial of the claim because the auditing
cardiologist determined that there was no reasonable medical
basis for the Green Form representations at issue. According to
the Trust, claimant’s attesting and attending physicians are not
entitled to deference. With respect to the level of
Ms. Petersen’s mitral regurgitation, the Trust notes that the
echocardiogram improperly includes low velocity flow as mitral
regurgitation. With respect to whether Ms. Petersen died as a
result of a condition caused by VHD or valvular
report/replacement surgery, the Trust maintains that the Estate
fails in its proof. While the Estate disputed the
“generalization that mild mitral regurgitation and/or aortic
regurgitation does not cause atrial and ventricular
fibrillation,” it did not dispute the auditing cardiologist’s
specific findings that: (1) Ms. Petersen’s August 1, 2017
echocardiogram showed normal left ventricular size,
systolic/diastolic function, and right ventricular function and
did not show any aortic regurgitation or pulmonary hypertension;
(2) there was no evidence of any structural or hemodynamic
impact from Ms. Petersen’s mitral regurgitation; and
(3) Ms. Petersen died after cardioversion for ventricular
tachycardia with no sign of congestive heart failure on the
chest x-ray or emergency department note of August 21, 2017.
The Technical Advisor, Dr. Vigilante, reviewed
claimant’s echocardiogram. He concluded that there was no
reasonable medical basis for finding that Ms. Petersen had
moderate mitral regurgitation or that she died as a result of a
condition caused by VHD or valvular report/replacement surgery.
Specifically, Dr. Vigilante stated, in pertinent part:
I reviewed the DVD and multiple
VHS tapes of the March 11, 2000
echocardiogram. These were all copies of
the same study. In addition, the name
“Michael S. Mancina, MD” was noted over the
top of the study. The usual
echocardiographic views were obtained. This
was a below quality study as it was quite
grainy and there was difficult endocardial
definition presumable due to the claimant’s
morbid obesity. However, the study was
diagnostic in evaluation of the issue in the
parasternal long-axis, apical four chamber,
and apical two chamber views. The Nyquist
limit was appropriately set at 64.1 cm per
second at a depth of 23.1 cm in the
parasternal long axis view as well as 67.3
cm per second at a depth of 20.1 cm in the
apical four chamber view and 64.1 cm per
second at a depth of 23.1 in the apical two
chamber view. However, there was excessive
color gain with color artifact noted outside
the cardiac chambers. . . . I digitized the
cardiac cycles in the apical four chamber
view in which the mitral regurgitant jet
appeared most impressive. I then measured
the RJA and LAA by electronic calipers. I
determined that the largest representative
RJA was 2.3 cm2. The LAA was 19.8 cm2.
Therefore, the largest representative
RJA/LAA ratio was 12% diagnostic of mild
mitral regurgitation. The ratio did not
come close to approaching the ratio of 20%.
The sonographer-measured RJA of 4.45 cm2 was
grossly inaccurate as it included low
velocity and non-regurgitant flow. In
addition, the sonographer-measured LAA was
inaccurately small as it is an off axis view
of the left atrium. Indeed, the left atrium
was dilated and the sonographer measurement
of the LAA of 15.8 cm2 is not consistent
with the left atrial enlargement. It should
be noted that the RJA was even smaller in
the apical two chamber view.
. . . .
In response to Question 1, there
is no reasonable medical basis for the
Attesting Physician’s representation that
Claimant’s March 11, 2000 echocardiogram
demonstrated moderate mitral regurgitation.
Without question, the echocardiogram
demonstrated mild mitral regurgitation with
comments as above. An echocardiographer
could not reasonably conclude that moderate
mitral regurgitation was present on this
study even taking into account inter-reader
variability.
In response to Question 2, there
is no reasonable medical basis for the
Attesting Physician’s answer to Green Form
Question L.4., which states that the Diet
Drug Recipient suffered death resulting from
a condition caused by [VHD] or valvular
repair/replacement surgery. That is, this
patient had, at most, mild mitral
regurgitation and mild aortic regurgitation
on multiple echocardiograms including the
transesophageal echocardiogram from October
8, 2015 and the echocardiogram of August
1,2017 which I reviewed. The last study
occurred only 20 days prior to her death.
The Diet Drug Recipient had never been
clinically diagnosed with any worse than
mild mitral regurgitation and mild aortic
insufficiency. There is no chance that
these mild valvular abnormalities caused the
Diet Drug Recipient's death. Instead, it is
obvious that her death occurred from an
uncontrollable and malignant ventricular
arrhythmia that was not related to her mild
valvular condition. This malignant
arrhythmia could be considered a
complication of her electrophysiologic
procedure that occurred less than one month
prior to her death. In addition, her
malignant arrhythmia was related to
pulmonary hypertension, significantly
dilated right sided cardiac chambers,
obstructive sleep apnea, hypertension, and
morbid obesity.
After reviewing the entire show cause record, the
court finds that the Estate has not established a reasonable
medical basis for its claim. Claimant does not adequately
refute the findings of the auditing cardiologist and Technical
Advisor that there is no reasonable medical basis for the
representation that Ms. Petersen’s echocardiogram demonstrates
moderate mitral regurgitation. As the court 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 echocardiogram settings; (5) setting a low
Nyquist limit; (6) characterizing “artifacts,” “phantom jets,”
“backflow” and other low velocity flow as mitral regurgitation;
(7) failing to take a claimant's medical history; and
(8) overtracing the amount of a claimant's regurgitation.
See Mem. in Supp. of PTO No. 2640 at 9–13, 15, 21–22, 26
(Nov. 14, 2002).
Dr. Wang and Dr. Vigilante each determined that the
echocardiogram demonstrated only mild mitral regurgitation.
Although claimant’s attesting physician submitted three images
from the echocardiogram that he claimed demonstrated moderate
mitral regurgitation, Dr. Wang determined that the “RJA
encircled on the study includes low velocity flow, falsely
inflating the RJA/LAA ratio.” Similarly, Dr. Vigilante
concluded that “there was excessive color gain with color
artifact noted outside the cardiac chambers” and that “[t]he
sonographer-measured RJA of 4.45 cm2 was grossly inaccurate as
it included low velocity and non-regurgitant flow.”
Such unacceptable practices cannot provide a
reasonable medical basis for the resulting diagnosis of mild
aortic regurgitation. To conclude otherwise would allow
claimants who do not have moderate mitral regurgitation to
receive Matrix Benefits. Such a result would be contrary to the
intent of the Settlement Agreement.
Furthermore, claimant does not adequately refute the
findings of the auditing cardiologist and Technical Advisor that
there is no reasonable medical basis for representing that
Ms. Petersen died as a result of a condition caused by VHD or
valvular report/replacement surgery. Dr. Wang determined that
Ms. Petersen’s death was not caused by VHD. He explained that
the echocardiogram taken immediately prior to her death “showed
normal left ventricular size, normal systolic/diastolic
function, normal right ventricular function, only mild mitral
regurgitation, no aortic regurgitation and no pulmonary
hypertension, . . . [and] no evidence of structural and
hemodynamic impact from mild mitral regurgitation.” She also
noted that mild mitral regurgitation and/or aortic regurgitation
does not cause atrial and ventricular fibrillation and that
Ms. Petersen did not have the long-standing severe regurgitation
that would cause left ventricular dilation and dysfunction.
Similarly, Dr. Vigilante similarly observed that
Ms. Petersen was never clinically diagnosed with more than mild
mitral regurgitation, which could not have caused her death.
Dr. Vigilante concluded that “her death occurred from an
uncontrollable and malignant ventricular arrhythmia that was not
related to her mild valvular condition.”
Dr. Tabbal, Ms. Petersen’s attending physician, did
not address Dr. Wang’s specific findings that: Ms. Petersen had
a normal left ventricular size, systolic/diastolic function, and
right ventricular function; did not have any aortic
regurgitation or pulmonary hypertension or evidence of any
structural or hemodynamic impact from her mitral regurgitation;
or that she died after cardioversion for ventricular tachycardia
with no sign of congestive heart failure.
Rather, Dr. Tabbal agreed that arrhythmias are more
commonly associated with severe levels of regurgitation but
provided one medical journal article and two abstracts that he
contended support his conclusion that mild regurgitation can
contribute to arrhythmias. However, Dr. Vigilante, after review
of these documents, explained that they related either to
patient populations or disease conditions that were not relevant
to Ms. Petersen and therefore did not support Dr. Tabbal’s
conclusion.
Claimant also argued that the reasonable medical basis
standard “is a relatively liberal standard where differing
medical opinions may fall within the scope of a reasonable
medical basis.” The court disagrees with claimant’s
interpretation of the reasonable medical basis standard. The
standard delineated in the Settlement Agreement and Audit Rules
must be applied. It requires a “reasonable medical basis” that
is more stringent than claimant contends. When, as here,
claimant and the attending physician fail to address the
auditing cardiologist’s specific findings, claimant fails to
satisfy the reasonable medical basis. See In re Diet Drugs
(Phentermine/Fenfluramine/ Dexfenfluramine) Prods. Liab. Litig.
(Venetz), 601 F. App’x 143, 147 (3d Cir. 2015) (citing In re
Diet Drugs (Phentermine/ Fenfluramine/Dexfenfluramine) Prods.
Liab. Litig. (Patterson), 543 F.3d 179, 190 (3d Cir. 2008)).
For the foregoing reasons, the court concludes that
the Estate has not met its burden of proving that there is a
reasonable medical basis for finding that Ms. Petersen had
moderate mitral regurgitation or that she died as a result of a
condition caused by VHD. Therefore, the Trust’s denial of the
Estate’s claim for Matrix A-1, Level V benefits will be
affirmed.