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 B. Pondimin and Redux were withdrawn from the market in the United States in 1997 after being linked to an increased risk of developing aortic and mitral heart valve disease, endocardial fibrosis,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 Page 2 of 14 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 Page 3 of 14 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. Page 4 of 14 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 Page 5 of 14 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. Page 6 of 14 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. Page 7 of 14 (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. Page 8 of 14 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. Page 9 of 14 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. Page 10 of 14 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. Page 12 of 14 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) Page 14 of 14
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