EXHIBIT H SETTLEMENT ELIGIBILITY CRITERIA. a) pharmacy records reflecting the dispensing of Bextra and/or Celebrex to the Class Member; or
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1 EXHIBIT H SETTLEMENT ELIGIBILITY CRITERIA 1. PRODUCT IDENTIFICATION DOCUMENTATION In order to be eligible for compensation under the Settlement Agreement, each Claimant must provide evidence of the Class Member s prescription and/or use of Bextra and/or Celebrex, including a clear indication as to dosage, such evidence to consist of one of the following: a) pharmacy records reflecting the dispensing of Bextra and/or Celebrex to the Class Member; or b) insurance records reflecting the Class Member s purchase of Bextra and/or Celebrex; or c) medical records reflecting the prescription or provision (samples) of Bextra and/or Celebrex and a statutory declaration by the Class Member (or the Class Member s representative) that the Class Member was prescribed and/or provided with Bextra and/or Celebrex, along with the dosage and dates of same; or d) in extraordinary circumstances only, to be determined by the Claims Administrator, if none of the above records are available, a declaration signed by the Class Member s physician attesting to the Class Member having been prescribed and/or provided with Bextra and/or Celebrex, including the dosage and dates of same, along with a statutory declaration by the Class Member (or the Class Member s representative) that the Class Member was prescribed and/or provided with Bextra and/or Celebrex, along with the dosage and dates of same. 2. DATE(S) OF USE AND DOSAGE CELEBREX ONLY Claims for Compensable Injuries (as defined infra.) by Class Members who ingested Celebrex only (and not Bextra) are limited to the following circumstances: a) use of Celebrex and the alleged Compensable Injury must have occurred prior to January 1, 2006; and b) the maximum quantum of compensation available for Compensable Injuries for Class Members who ingested Celebrex only (and not Bextra) varies depending on the daily dosage of Celebrex prescribed and ingested by Class Members (specifically, whether 400mg or <400mg daily) as more particularly set out infra. at s. 4 and in the Compensation Grid
2 2 (Exhibit I to the Settlement Agreement), which daily dosage must be established by the Product Identification Documentation submitted in support of a claim. 3. DEFINITION AND EVIDENCE OF COMPENSABLE INJURIES In order to be eligible for compensation under the Settlement Agreement, a Class Member must have suffered one of the following Compensable Injuries contemporaneous with their use of Bextra and/or Celebrex: a) Myocardial Infarction (Heart Attack) is established by one or more of the following: i) a final or discharge diagnosis in contemporaneous medical records of a myocardial infarction or heart attack; or i iv) a diagnosis or affirmative finding in the contemporaneous medical records (e.g. a report of consultation) by a cardiologist of a myocardial infarction or heart attack; or, within 14 days of discharge from a hospitalization for the alleged Compensable Injury, an independent diagnosis by a treating cardiologist that the Class Member suffered a myocardial infarction or heart attack; or if the contemporaneous medical records are silent as to whether or not there was a myocardial infarction or heart attack, new pathological Q waves in two or more contiguous leads; or if the contemporaneous medical records are silent as to whether or not there was a myocardial infarction or heart attack, (a) signs and symptoms described in contemporaneous medical records of a heart attack (including, but not limited to chest pain, pressure, tightness or discomfort, pain or discomfort in the upper areas of the body including but not limited to one or both arms, the back, neck, jaw or stomach, or shoulders; shortness of breath, weakness, dizziness, cold sweat, or excessive sweating, nausea, fatigue, loss of consciousness or posture, lightheadedness, feeling of faintness, heart-burn or indigestion sensations, feelings of restlessness or anxiousness, a sense of impending doom, disorientation, lips, hands or feet turning slightly blue, abnormal heart rhythms (arrhythmias), or loss of consciousness, cardiac arrest, blood pressure fluctuations or drops requiring medical intervention) or new ischemic ST-T wave changes on an electrocardiogram in two or more contiguous leads; and
3 3 (b) a rise and fall of cardiac enzymes that includes a rise in serum creatine kinase MB (CK-MB) to greater than two times the upper limit of normal or a rise in serum cardiac troponin greater than two-times the upper limit of normal that is considered by the laboratory to be diagnostic for infarctions (if the laboratory result does not reflect the normal diagnostic range for troponin that is used by that laboratory, a rise in the troponin to greater than 1.5 ng/ml shall be deemed to indicate a myocardial infarction); and v) an alleged Compensable Injury will NOT be deemed a myocardial infarction or heart attack if myocardial infarction and/or heart attack is ruled out as a diagnosis in the discharge summary or by an in-house cardiology consultation at the time of the alleged Compensable Injury, or the final diagnosis is angina or unstable angina; b) Ischemic Stroke is established by one or more of the following: i) a final or discharge diagnosis in contemporaneous medical records of an ischemic stroke or ischemic cerebrovascular event or accident (i.e. ischemic stroke, intracranial thrombosis, cerebral embolism, thrombotic stroke, embolic stroke, lacunar infarct, lacunar stroke, thrombotic occlusion, cerebrovascular event or accident that is not a primary hemorrhagic event, and cerebral infarction; or a hemorrhagic stroke that is secondary to the terms previously listed); or i if the final or discharge diagnosis is silent as to whether or not the Class Member had an ischemic stroke as defined above, but there is a diagnosis or affirmative finding in the contemporaneous medical records (i.e. a report of consultation) by a neurologist of an ischemic stroke; or, within 14 days of discharge from the hospitalization related to the alleged Compensable Injury, there is an independent diagnosis by a treating neurologist that the alleged Compensable Injury was an ischemic stroke; and an alleged Compensable Injury will NOT be deemed an ischemic stroke if: (a) stroke or cerebrovascular accident is ruled out as a diagnosis in the discharge summary or by a treating neurologist within 14 days of discharge from the hospitalization related to the alleged Compensable Injury; or
4 4 (b) hemorrhagic stroke or hemorrhagic cerebrovascular accident is the diagnosis in the discharge summary or by a treating neurologist within 14 days of discharge from the hospitalization related to the alleged Compensable Injury (this exclusion does not apply to a hemorrhagic stroke that is secondary to an ischemic stroke; or (c) transient ischemic attack is the diagnosis in the discharge summary or is the diagnosis of a treating neurologist within 14 days of discharge from the hospitalization related to the alleged Compensable Injury. c) Severe Cutaneous Adverse Reaction (SCAR) (for Bextra users only) includes Stevens-Johnson syndrome and toxic epidermal necrolysis and is established by one or more of the following: i) a final or discharge diagnosis in contemporaneous medical records of Stevens-Johnson syndrome or toxic epidermal necrolysis; or i if the final or discharge diagnosis is silent as to whether or not the Class Member had a diagnosis of Stevens-Johnson syndrome or toxic epidermal necrolysis, but there is a diagnosis or affirmative finding in the contemporaneous medical records (i.e. a report of consultation) of Stevens-Johnson syndrome or toxic epidermal necrolysis; or, within 14 days of discharge from the hospitalization related to the alleged Compensable Injury, there is an independent diagnosis by a treating physician that the alleged Compensable Injury was Stevens-Johnson syndrome or toxic epidermal necrolysis; and an alleged Compensable Injury will NOT be deemed to be Stevens-Johnson syndrome or toxic epidermal necrolysis if Stevens-Johnson syndrome or toxic epidermal necrolysis is/are ruled out as a diagnosis in the discharge summary or by a treating physician within 14 days of discharge from the hospitalization related to the alleged Compensable Injury. d) Other Cardiac, Renal or Vascular Events include the following: i) New Onset Congestive Heart Failure is established by one or more of the following: a) a final or discharge diagnosis in contemporaneous medical records of new onset congestive heart failure; or b) a diagnosis or affirmative finding in the contemporaneous medical records (e.g. a report of consultation) by a
5 5 cardiologist of new onset congestive heart failure; or, within 14 days of discharge from a hospitalization for the alleged Compensable Injury, an independent diagnosis by a treating cardiologist or internist that the Class Member suffered from new onset congestive heart failure; or c) if the medical records are silent as to a positive diagnosis or affirmative finding of new onset congestive heart failure, contemporaneous medical records reflecting either two of the major criteria or one major and at least two minor Framingham Criteria 1. Acute Renal Failure/Acute Kidney Injury is established by one or more of the following: a) a final or discharge diagnosis in contemporaneous medical records of acute renal failure/acute kidney injury; or b) a diagnosis or affirmative finding in the contemporaneous medical records (e.g. a report of consultation) of acute renal failure/acute kidney injury; or, within 14 days of discharge from a hospitalization for the alleged Compensable Injury, 1 Major criteria: Paroxysmal nocturnal dyspnea Neck vein distention Rales Radiographic cardiomegaly (increasing heart size on chest radiography) Acute pulmonary edema S3 gallop Increased central venous pressure (>16 cm H2O at right atrium) Hepatojugular reflux Weight loss >4.5 kg in 5 days in response to treatment Minor criteria: Bilateral ankle edema Nocturnal cough Dyspnea on ordinary exertion Hepatomegaly Pleural effusion Decrease in vital capacity by one third from maximum recorded Tachycardia (heart rate>120 beats/min.) Minor criteria are acceptable only if they can not be attributed to another medical condition (such as pulmonary hypertension, chronic lung disease, cirrhosis, ascites, or the nephrotic syndrome).
6 6 an independent diagnosis that the Class Member suffered from acute renal failure/acute kidney injury; or c) if the contemporaneous medical records are silent as to a positive diagnosis of acute renal failure/acute kidney injury, laboratory reports reflecting acute renal failure/acute kidney injury. i Miscellaneous Thromboembolic Event; a) a final or discharge diagnosis in contemporaneous medical records of a thromboembolic event; or b) a diagnosis or affirmative finding in the contemporaneous medical records (e.g. a report of consultation) of a thromboembolic event; or, within 14 days of discharge from a hospitalization for the alleged Compensable Injury, an independent diagnosis that the Class Member suffered from a thromboembolic event; or c) if the contemporaneous medical records are silent as to a positive diagnosis of a thromboembolic event, laboratory results and/or other records reflecting such clinical findings. 4. VALUES FOR COMPENSABLE INJURIES The amount of compensation that shall be payable to Claimants under the Settlement Agreement shall be determined by reference to the Compensation Grid. With respect to claims for Compensable Injuries by Class Members who ingested Celebrex only (and not Bextra), the maximum quantum of compensation shall be determined as follows: a) for Class Members whose total daily dosage of Celebrex (as established by the Product Identification Documentation submitted in support of the claim) was 400mg, $100,000 for Fatal and Non -Fatal Myocardial Infarction and Ischemic Stroke and $10,000 for Other Cardiac, Renal or Vascular Event; and b) for Class Members whose total daily dosage of Celebrex (as established by the Product Identification Documentation submitted in support of the claim) was <400mg, $25,000 for Fatal and Non-Fatal Myocardial Infarction and Ischemic Stroke and $5,000 for Other Cardiac, Renal or Vascular Event, subject to possibly being increased as set out in s.11 of the Settlement Agreement and the Compensation Grid.
7 7 5. INCOME LOSS Class Members, or their representatives, shall be entitled to submit an Income Loss Claim in accordance with the procedures for so doing, as set out in the Compensation Grid and the Claims Administration Procedures (Exhibit J to the Settlement Agreement). Income losses which may be recovered shall be determined based on the difference between the Class Member s average net income in the three (3) years prior to the alleged Compensable Injury and the Class Member s average net income following the alleged Compensable Injury. All such claims shall be initially restricted to a maximum claim period of 3 years following the Compensable Injury, however, Income Loss Claims in excess of three years may be payable if funds remain in the amount notionally allocated in s.11.2(b) of the Settlement Agreement and upon an application by Plaintiffs Counsel to the Québec and Ontario Courts, in accordance with s.11.4 of the Settlement Agreement. 6. DERIVATIVE CLAIMS The spouses, children and parents of Class Members who suffered from a Compensable Injury ( Derivative Claimants ) shall be entitled to compensation in relation to their derivative claims in accordance with the Compensation Grid. In particular, Derivative Claimants shall be entitled to payment of 10% of the value of their associated Class Member s Compensable Injury, however the total value of all Derivative Claims associated with a single Class Member shall be capped at $30,000. If the aggregate total of all claims for Compensable Injuries and Derivative Claims exceeds the amount notionally allocated from the Settlement Fund for such claims, all Derivative Claims shall be subject to a pro rata reduction, with the possibility of being topped-up, in accordance with s.11.6 of the Settlement Agreement. 7. CONSUMER CLAIMS All Class Members who purchased Bextra and/or Celebrex (in the case of Celebrex, such purchase must have occurred prior to January 1, 2006) are entitled to submit a Consumer Claim in accordance with the Compensation Grid; in particular, claims may be made for the payment of $300 upon submission of documentary evidence of such purchase(s). If the aggregate total of all Consumer Claims exceeds the amount notionally allocated from the Settlement Fund for Consumer Claims, all Consumer Claims shall be subject to a pro rata reduction.
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