Deadlines, Dollar Values and Qualifying Injuries

2015 Fen Phen Update
Guide to Prerequisites, Deadlines, Dollar Values, and Qualifying Injuries
In The AHP Settlement Trust
By Cynthia K. Garrett, Attorney at Law – Representing Fen Phen users since 1998i
I.
Introduction................................................................................................................ 1
II. Echocardiography ..................................................................................................... 2
III. Basic Requirements Before A Matrix Claim Will Be Processed ................................. 3
IV. Deadlines ................................................................................................................... 4
V. Matrix Compensation Dollar Values .......................................................................... 6
VI. Matrix-A versus Matrix-B ........................................................................................... 6
VII. Matrix Compensation Injuries.................................................................................... 9
VIII. Matrix Level I ............................................................................................................. 9
IX. Matrix Level II ............................................................................................................ 9
X. Matrix Level III through V........................................................................................... 10
XI. Useful Links............................................................................................................... 12
I.
Introduction
A.
Fen-Phen is the popularized name of a weight loss protocol that
combined phentermine with either fenfluramine (Pondimin®) or
dexfenfluramine (Redux™).
B.
Pondimin and Redux were withdrawn from the market in the United States
in 1997 after being linked to an increased risk of developing aortic and
mitral heart valve disease, endocardial fibrosis, and primary pulmonary
hypertension. Both were manufactured by American Home Products
(AHP). AHP changed its name to Wyeth in 2002. Wyeth was purchased
by Pfizer in 2009.
C.
Federal jurisdiction of all Pondimin and Redux personal injury litigation is
consolidated in the United States District Court for the Eastern District of
Pennsylvania under docket MDL-1203 (MDL-1203 Court).
D.
A class-action settlement agreement, known as the Nationwide Class
Action Settlement With American Home Products Corporation (AHP
Settlement Agreement) was entered into between AHP and plaintiffs’
Class Counsel in 1999. The agreement received preliminary judicial
approval in 2000, and final judicial approval in 2002.
E.
The AHP Settlement Trustii was established in 2000 by the order of the
MDL-1203 Court, and continues to administer the valvular injury claims of
registered Pondimin and Redux users, known as Diet Drug Recipients
(DDRs).
Page 1 of 14
F.
II.
Matrix Compensation Benefits claims may be filed by those DDRs who
currently meet the criteria found in the AHP Settlement Agreement, the
orders of the MDL-1203 Court, and the court-approved policies and
procedures of the AHP Settlement Trust.
Echocardiography
A.
The primary evidentiary material in the AHP Settlement is
echocardiography. For all purposes within the AHP Settlement,
echocardiograms must meet the following standards:iii
1.
Echocardiograms performed after September 30, 1999, are to be
conducted in accordance with the standards and criteria as outlined
in Feigenbaum or Weyman,iv using the grading system of valvular
regurgitation defined in Singhv.
2.
The following degrees of severity are utilized in the AHP
Settlement.
a)
Aortic heart valve regurgitation is measured in the
parasternal long axis view (PLAX) or the apical long-axis
view if the PLAX view is not available. The measurement is
formulated as a percentage equal to jet height over left
ventricular outflow tract height (JH/LVOTH).
Mild:
Moderate:
Severe:
b)
Mitral heart valve regurgitation is measured in any apical
view (A4). The measurement is formulated as a percentage
equal to regurgitant jet area over left atrial area (RJA/LAA).
Mild:
Moderate:
Severe:
c)
10% - 24%
25% - 49%
> 49%
6% - 19%
20% - 40%
> 40%
FDA Positive regurgitation is: mild or greater regurgitation of
the aortic valve and/or moderate or greater regurgitation of
the mitral valve, without any of the complicating factors
contained in Level II.vi
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B.
III.
For mitral regurgitation, the echocardiogram study must meet the following
requirements:vii
1.
The regurgitant jet must clearly originate in the mitral valve with no
black space or apparent void between the valve and the jet.
2.
The regurgitant jet must follow the QRS complex and be sustained
during systole so that it is > than 1/10th of a second, and present for
more than two frames.
3.
The regurgitant jet must be seen in multiple beats spreading into
the left atrium during systole.
4.
The regurgitant jet must be seen as aliasing in multiple beats,
evidencing high velocity and turbulence in the jet; and
5.
The freeze frame evidence shows an aliasing jet with a
corresponding loop in real time.
Basic Requirements Before A Matrix Claim Will Be Processed
A DDR must first meet the following basic requirements before the AHP
Settlement Trust will process evidence of a Matrix Compensation Level injury:viii
1.
DDR registration with the AHP Settlement Trust by no later than
May 3, 2003.ix
2.
Provide proof of use of Pondimin or Redux.x
3.
Baseline Injury: Provide proofxi of an echocardiogram ─ performed
after the DDR’s first use of Pondimin or Redux and before the end
of the Screening Period ─ which shows mild or greater aortic or
mitral heart valve regurgitation.xii The screening period ended on
July 3, 2003, for echocardiograms provided by the AHP Settlement
Trust, and on January 3, 2003, for all others.
4.
Submit a fully completed and properly executed Green Form.xiii,xiv
Part II must be completed and signed by a Board-Certified
cardiologist or Board-Certified cardiothoracic surgeon, with at least
level two echocardiography training.xv Green Form question F.11
regarding functional outcome six months after a stroke, may be
completed by a Board-Certified neurologist or Board-Certified
neurosurgeon.xvi
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5.
6.
IV.
Submit Medical Information relating to the medical condition that is
the basis of the Matrix Level claim, including:xvii
a)
Hospital reports of admitting history and physical
examinations.
b)
Cardiac catheterization reports.
c)
Hospital discharge summaries.
d)
Operation or surgery reports.
e)
Pathology reports.
f)
Written report and a copy of the videotape or disk of the
echocardiogram upon which the current claim is based.xviii
g)
For Matrix Levels III, IV or V: submission of those records
and documents required within the definition of the qualifying
injury that is the basis of the current claim, as found in
Section IV.B.2.c(3) of the Settlement Agreement.
Where a Claimant is unable to obtain the documentation described
above, the Trustee may consider other supporting documentation
as set out in the AHP Settlement Agreement, Sections VI.C.2.e-f
(Pages 91-93) and VI.C.4.b (Page 105).
Deadlines
Deadlines apply to when the medical condition that is the basis of the current
claim must be diagnosed in order to qualify for compensation, and when the
claim for that injury must be filed.
A.
Deadline To File A Matrix Compensation Claim
The deadline for filing a Matrix Compensation claim with the AHP
Settlement Trust is the later of November 8, 2014, or four years from the
date the qualifying injury is first diagnosed.xix
B.
Required Timing of Qualifying Injuries
Qualifying injuries must be diagnosed after the DDR’s first use of
Pondimin or Redux, and prior to the DDR’s 80th birthday.xx Beyond that,
what injuries qualify, and when they must occur, depends on whether the
DDR participated in the Seventh Amendment Supplemental Fund.
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1.
DDR Did Not Participate In The Seventh Amendment
Supplemental Fund:
a)
Have Not Yet Received Matrix Compensation
DDRs who opted-out of the Seventh Amendment
Supplemental Fund and have not yet received Matrix
Compensation Benefits may file Original Claims for Matrix
Compensation Level I through V injuries that are diagnosed
between first use of the Pondimin or Redux and December
31, 2015.xxi,xxii
b)
Have Already Received Matrix Compensation
(1)
(2)
2.
A Supplemental Claim (also referred to as Worsened
Injury Claims or Progression Claims) can be filed for a
DDR who:
(a)
Did not participant in the Seventh Amendment
Supplemental Fund;
(b)
Has already received Matrix Compensation
Benefits from the AHP Settlement Trust; and
(c)
Has been diagnosed with an injury which
currently qualifies for a Matrix Compensation
Benefits Level and dollar value above any
previous award.
The Original Claim will have met the Matrix cut-off
date of December 31, 2015. Therefore, the injury may
occur at any time before the DDR’s 80th birthday.xxiii
DDR Participated In The Seventh Amendment Supplemental
Fund:
a)
A Supplemental Claim can be filed for a DDR who
participated in the Seventh Amendment Supplemental Fund,
and has been diagnosed with an injury which qualifies for a
Seventh Amendment Matrix Compensation Benefits Level
and dollar value above any previous award.
b)
Seventh Amendment Matrix Compensation Benefits are a
modification of the original AHP Settlement Trust Matrix
Compensation Benefits for Levels III through V.xxiv
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c)
V.
VI.
The worsened injury that is the basis of the Supplemental
Claim must be diagnosed within 15 years of the DDR’s last
use of Pondimin or Redux, but no later than December 31,
2011.xxv
Matrix Compensation Dollar Values
A.
The initial settlement values for each of the five Matrix Compensation
Levels under both Matrix-A and Matrix-B are provided on page 38 of the
AHP Settlement Agreement. Beginning in 2003, the year after final judicial
approval, those values increase by two percent (2%) each year,
compounded annually.xxvi
B.
To calculate a 2015 settlement value, multiply the applicable dollar
amount found on page 38 of the AHP Settlement Agreement by a factor of
1.2936.
C.
A DDR with injuries that satisfy the requirements of more than one Matrix
Compensation Level of injury, will be awarded compensation for the
highest level for which he or she qualifies.xxvii
D.
If injuries to both the aortic valve and the mitral valve qualify for
compensation, the DDR will receive the greater of the two benefits, not
both.xxviii
E.
The dollar amount that a successful Claimant will be awarded is the Matrix
Compensation Benefit the DDR is currently entitled to, less any Matrix
Compensation Benefits previously awarded by the AHP Settlement Trust,
and less all benefits of any kind awarded by the Seventh Amendment
Fund Administrator.xxix, xxx
Matrix-A versus Matrix-B
Matrix Compensation is calculated on either Matrix-A or Matrix-B.xxxi Matrix-B
values are twenty percent (20%) of Matrix-A values.
A.
Matrix-Axxxii will be used when the Claimant has met the requirements of
Pretrial Court Order No. 2805 and Court Approved Procedure No. 4,
providing sufficient proof that:
1.
DDR ingested Pondimin and/or Redux for 61 days or more.
2.
DDR was diagnosed with at least FDA positive regurgitation after
first use of Pondimin or Redux and before the end of the Screening
Period.
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3.
B.
C.
No Matrix-B conditions were present before, or at the time of, the
injury that is the basis of the current claim.xxxiii
Matrix-Bxxxiv will be used under any of the following circumstance:
1.
The DDR ingested Pondimin and/or Redux for 60 days or less.
2.
One or more Matrix-B conditions were present before, or at the time
of, the injury that is the basis of the current claim. See endnote to
A.3 above.
3.
There is insufficient evidence on file to determine if Matrix-B
conditions were or were not present.xxxv
Matrix-B Conditions, also known as Reduction Factors or Alternate
Causation Factors, include:xxxvi
1.
For mitral valve claims:
a)
Moderate or greater mitral regurgitation prior to Pondimin or
Redux use.
b)
Mild is the highest degree of mitral regurgitation which the
DDR was diagnosed with after first use of Pondimin and
before the end of the Screening Period.
2.
For aortic valve claims: mild or greater aortic regurgitation prior to
Pondimin or Redux use.
3.
Any of the following conditions were present prior to, or at the time
of, the injury that is the basis of the current claim:
a)
For aortic valve claims:
(1)
Congenital abnormalities including: unicuspid,
bicuspid or quadricuspid aortic valve, ventricular
septal defect.
(2)
Aortic dissection involving the aortic root and/or aortic
valve.
(3)
Aortic sclerosis in DDRs ≥ 60 years old when first
diagnosed as FDA Positive.
(4)
Aortic root dilation > 5.0 cm.
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(5)
b)
c)
Aortic stenosis with aortic value area < 1.0 square
centimeter by the Continuity Equation.
For mitral valve claims:
(1)
Congenital abnormalities including: parachute valve,
cleft of the mitral valve associate with atrial septal
defect.
(2)
Mitral Valve Prolapse – where PLAX view shows
displacement of one or both leaflets >2 mm above the
atrial-ventricular boarder during systole, and >5 mm
leaflet thickening during diastole.xxxvii
(3)
Chordae tendineae rupture or papillary muscle
rupture; or acute myocardial infarction associated with
acute mitral regurgitation,
(4)
Mitral annular calcification.
(5)
Rheumatic mitral valve evidenced by
echocardiography showing doming of the anterior
leaflet and/or anterior motion of the posterior leaflet
and/or commissural fusion, except where a BoardCertified Pathologist has examined the extracted
valve and determine that it was not rheumatic. The
pathology exception is not available for DDRs who
participated in the Seventh Amendment.
As to both mitral and aortic valve claims:
(1)
Heart valve surgery prior to first use of Pondimin or
Redux on the valve that is the basis of the claim.
(2)
Bacterial endocarditis prior to Pondimin or Redux use.
(3)
Systemic Lupus Erythematosus or Rheumatoid
Arthritis and valvular abnormalities associated with
those conditions.
(4)
Carcinoid tumor of a type associated with aortic or
mitral valve lesions.
(5)
History of daily use of methysergide or ergotamines
for a period of > 120 days.
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VII.
VIII.
IX.
Matrix Compensation Injuries
A.
Cautionary Note: There is no substitute for a close examination of the
exact definitions and limitations as found in the official settlement
documents.
B.
The original AHP Settlement Agreement’s definitions of the five Matrix
Compensation Levels can be found on pages 39 through 47 of the AHP
Settlement Agreement. Those definitions can be accessed by clicking
here.
C.
The Seventh Amendment removed the availability of Matrix Compensation
Benefits Levels I and II, and modified the definitions of Levels III, IV and V,
for those DDRs who participated in the Seventh Amendment
Supplemental Fund. The Official Court Notice-Appendix F is a summary of
those changes and can be accessed by clicking here.
Matrix Level I
A.
Not available to DDRs who participated in the Seventh Amendment
Supplemental Fund.
B.
Level I is:
1.
Severe aortic or mitral regurgitation with none of the complicating
factors listed in Level II applicable to the affected valve.
2.
FDA Positive regurgitation with bacterial endocarditis contracted
after first use of Pondimin or Redux.
Matrix Level II
A.
Not available to DDRs who participated in the Seventh Amendment
Supplemental Fund.
B.
Moderate or greater aortic regurgitation with one or more of the following
complicating factors:
a)
Pulmonary hypertension secondary to severe aortic
regurgitation with peak pulmonary arterial pressure of >40
mmHg measured by catheterization, or >45 mmHg
measured by echocardiogram, at rest, utilizing a right atrial
pressure of 10 mmHg.
b)
Abnormal left ventricular end-diastolic dimension >7.0 cm, or
abnormal left ventricular end-systolic dimension ≥ 5.0 cm.
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c)
C.
X.
Low ejection fraction of < 50%.
Moderate or greater mitral regurgitation with one or more of the following
complicating factors:
a)
Pulmonary hypertension secondary to moderate or greater
mitral regurgitation with peak pulmonary arterial pressure of
>40 mmHg measured by catheterization, or >45 mmHg
measured by echocardiogram, at rest, utilizing a right atrial
pressure of 10 mmHg.
b)
Abnormal left atrial supero-inferior systolic dimension >5.3
cm (A4 view) or abnormal left atrial antero-posterior systolic
dimension >4.0 cm in PLAX view with normal sinus rhythm.
c)
Abnormal left ventricular end-systolic dimension ≥4.5 cm.
d)
Low ejection fraction of: ≤ 60%.
e)
Chronic atrial fibrillation/flutter with left atrial enlargement,
where the arrhythmia cannot be converted to normal sinus
rhythm, or which requires ongoing medical therapy.
Matrix Level III through V
A.
These high-level injuries have prerequisites as to regurgitation levels,
complicating factors, compounding injuries and time limitations. The
particular requirements for each injury, are included in the definition for
that injury as found on pages 42-48 of the AHP Settlement Agreement.
See Cautionary Note at Section VII above.
B.
The Seventh Amendment modified the requirements for Levels III through
V, for those DDRs who participated in the Seventh Amendment
Supplemental Fund. See Section XI.E below for more information.
C.
General descriptions of the injuries included in Matrix Levels III, IV and V
follow:
1.
Aortic or mitral heart valve repair or replacement surgery has been
performed.
2.
Severe aortic or mitral heart valve regurgitation where repair or
replacement surgery is needed but cannot be performed due to
other health risks. Not available for Seventh Amendment
participants except where Level IV or V conditions are also present.
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3.
Complications from aortic or mitral heart valve surgery including:
a)
Infection of the surgical site requiring reopening of the
median sternotomy.
b)
Peripheral embolus, within thirty days after surgery or during
the same hospital stay, resulting in severe permanent
impairment to the kidneys, abdominal organs, or extremities.
c)
Severe kidney failure, within 30 days after surgery or during
that same hospital stay, requiring dialysis for greater than six
months,
d)
Quadriplegia or paraplegia, within 30 days after surgery or
during the same hospital stay, due to a spinal injury during
valve surgery,
e)
HIV or Hepatitis C diagnosed within six months of aortic or
mitral heart valve surgery that required a blood transfusion.
f)
A stroke caused by valve surgery which results in a
permanent condition which meets the criteria of AHA Stroke
Outcome Classification System Functional Levels II or higher
determined six months after the stroke.
4.
A second surgery to the same valve within eighteen months of the
first.
5.
Irreversible pulmonary hypertension secondary to heart valve
disease defined as peak-systolic pulmonary artery pressure > 50
mmHg by catheterization, at rest, following aortic or mitral valve
surgery.
6.
Ventricular fibrillation or ventricular tachycardia resulting in
hemodynamic compromise.
7.
Ejection fraction <40% six months or more after aortic or mitral
valve surgery, with NYHA Functional Class I or higher symptoms.
8.
Ejection fraction <35% for the mitral valve or <30% for the aortic
valve, with NYHA Functional Class I or higher symptoms, where
repair or replacement surgery is needed but cannot be
performed due to other health risks.
9.
Peripheral embolus due to bacterial endocarditis or atrial fibrillation
with left heart enlargement resulting in: severe renal failure
Page 11 of 14
requiring dialysis for more than six months, abdominal organ
damage requiring surgery, or amputation of an arm, leg, hand or
foot.
XI.
10.
A heart transplant.
11.
Stroke due to either bacterial endocarditis or chronic aortic
fibrillation due to mitral heart valve disease with left atrial
enlargement, and AHA Stroke Outcome Classification System
Function Level II or higher determined six months after the stroke.
12.
Persistent non-cognitive state caused by complications of aortic or
mitral heart valve disease or valvular surgery.
13.
Death resulting from a condition caused by aortic or mitral heart
valve disease or valvular surgery.
Useful Links
A.
The AHP Settlement Trust’s web site is: settlementdietdrugs.com.
B.
The deadline for the filing of valvular injury claims was established by MDL
1203 Pretrial Order No. 8559 and Court Approved Procedure No. 16.
Both may be accessed by clicking here.
C.
The AHP Settlement Agreement (as amended by the First through Sixth
Amendments) can be accessed by clicking here. The definitions of the
original Matrix Compensation Levels I through V can be found on pages
39 through 48 there.
D.
Seventh Amendment Matrix Compensation Benefits are a modification of
the original Matrix Compensation Benefits. The Seventh Amendment
document can be accessed by clicking here.
E.
The Official Court Notice containing a comparison of the original and
Seventh Amendment Level III through V injuries can be accessed by
clicking here and reviewing Appendix F of the linked document.
F.
Substantial medical records are required to be considered for Matrix-A
benefits. Those requirements are found in Pretrial Order No. 2805 and
Procedure No. 4. They may be accessed by clicking here.
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Author:
Cynthia K. Garrett
Attorney at Law
P.O. Box 1550
Jenks, OK 74037-1550
Telephone: (918) 584-0070
Email: [email protected]
Web Site: CynthiaKGarrett.com
Representing Fen Phen claimants since 1998
Disclaimer: Cynthia K. Garrett is not associated with, and does not represent, the AHP
Settlement Trust. This guide reflects the author’s interpretation of the official documents
which govern or influence the administration of the AHP Settlement Trust. Nothing in
this guide is intended to be, nor should be construed as, legal advice
END NOTES:
Cynthia K. Garrett is not associated with, and does not represent, the AHP Settlement Trust. This guide reflects the author’s
interpretation of the official documents which govern or influence the administration of the AHP Settlement Trust. Nothing in this
guide is intended to be, nor should be construed as, legal advice.
i
ii
The AHP Settlement Trust contact information: 1100 E. Hector St., Suite 450, Conshohocken, PA 19428. Toll-Free Telephone: 1800-386-2070.
iii
AHP Settlement Agreement, Section VI.C.1.b (Page 89)
iv
To qualify, an echocardiogram must be conducted as outlined in one of the following:
Harvey Feigenbaum, Echocardiography 68-133 (5th ed. 1994), or, Arthur E. Weyman, Principals and Practice of Echocardiography
75-97 (2d ed. 1994).
v
J.P. Singh, et al., Prevalence of Clinical Determinants of Mitral, Tricuspid and Aortic Regurgitation (The Framingham Heart Study),
83 Am. J. Cardiology 897, 898 (1999)
vi
AHP Settlement Trust, I.22 (page 5-6)
This criteria reflects the MDL-1203 Court’s interpretation of the proper measurement and assessment of mitral regurgitation.
Discussion can be found in Pretrial Order No. 2640, and in the Seventh Amendment, Section XV.B.2.b (Pages 71-72)
vii
AHP Settlement Agreement, VI.C.4.a (Bottom of Page 104 – Top of Page 105)
viii
ix
AHP Settlement Agreement, IV.B.1 (Page 37)
x
AHP Settlement Agreement, VI.C.2.d (Pages 90-91)
xi
Normally, proof takes the form of the video and written report of the echocardiogram. However, if the video is no longer in
existence, the Claimant may take the actions described in the AHP Settlement Agreement, Sections VI.C.2.e-f (Page 91-93) and
VI.C.4.b (Page 105).
xii
AHP Settlement Agreement, IV.B.1.a (Page 37)
xiii
AHP Settlement Agreement, VI.C. 2.c (Page 90)
xiv
AHP Settlement Agreement, VI.C.4.a (Bottom of Page 104 – Top of Page 105)
xv
AHP Settlement Agreement, VI.C.2.g
xvi
AHP Settlement Agreement, VI.C.4.a(5) (Page 104)
xvii
AHP Settlement Agreement, VI.C.4.a (Pages 103-105)
Page 13 of 14
xviii
AHP Settlement Agreement, VI.C.4.a(2) (Page 103)
xix
MDL 1203 Pretrial Order No. 8559 and Court Approved Procedure No. 16, Section 5.
xx
AHP Settlement Agreement, Section IV.B.2.a-b (Pages 38-39)
xxi
The Matrix Payment Cut-Off Date for valvular claims is December 31, 2015. AHP Settlement Agreement, Section IV.C.2 (Page
54)
xxii
The Matrix Payment Cutoff Date and other deadlines for Endocardial Fibrosis claims were unique. To qualify for this Level V
Matrix Compensation Benefit, valvular regurgitation was not required. However, the AHP Settlement Agreement, Section IV.C.3
required that endocardial fibrosis be diagnosed by September 30, 2005, and the DDR register with the AHP Settlement Trust by
January 31, 2006. Therefore, pursuant to these limitations and Pretrial Order No. 8559, the time to file any endocardial fibrosis
claim would have ended no later than November 8, 2014.
xxiii
AHP Settlement Agreement, Section IV.C.2 (Page 54)
xxiv
Modifications are found in the Seventh Amendment, Section I.30.a-e (Pages 7-9). A comparison of the AHP Matrix
Compensation Benefits and the Seventh Amendment Matrix Compensation Benefits can be found in the 7 th Amendment Notice, Part
2, Appendix F. See Useful Links above.
xxv
Seventh Amendment to the AHP Settlement Agreement, Section IX.A.1.a (Page 50)
xxvi
AHP Settlement Agreement, Section IV.C.1 (Page 54)
xxvii
AHP Settlement Agreement, Section IV.B.2.f (Page 52)
xxviii
AHP Settlement Agreement, Sections IV.B.2.f (Page 52)
xxix
AHP Settlement Agreement, Section IV.C.3 (Page 54)
xxx
Seventh Amendment to the AHP Settlement Agreement, Section IX.A.2 (Page 51)
xxxi
AHP Settlement Agreement, Section IV.B.2.d (Pages 48-51)
xxxii
AHP Settlement Agreement, Section IV.B.2.d(1) (Page 48)
xxxiii
AHP Settlement Agreement, Section IV.B.2.d(2) (Pages 48-51)
xxxiv
AHP Settlement Agreement, Section IV.B.2.d(2) (Page 48-51)
xxxv
Pretrial Order No. 2805 and Court Approved Procedure No. 4
xxxvi
AHP Settlement Agreement, Section IV.B.2.d(2) (Page 48-51)
xxxvii
AHP Settlement Agreement, Section I.39 (Page 7)
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