Case 2:14-md-02592-EEF-MBN Document 1785 Filed 12/17/15 Page 1 of 5 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA



Similar documents
XARELTO BLEEDING RISKS AND POTENTIALLY FATAL SIDE EFFECTS

2:14-mn RMG Date Filed 05/09/14 Entry Number 128 Page 1 of 3

ORDER FOR PERMANENT INJUNCTION. under 26 U.S.C and 7407 from directly or indirectly;

Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 1 of 49 PageID 68

Case MDL No Document 122 Filed 12/12/14 Page 1 of 6. UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION TRANSFER ORDER

Case MDL No Document 1-1 Filed 10/09/14 Page 1 of 17 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION

Case 2:15-cv Document 1 Filed 03/20/15 Page 1 of 42 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF LOUISIANA

The largest clinical study of Bayer's Xarelto (rivaroxaban) Wednesday, 14 November :38

BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION ) ) ) ) ) )

Bios 6648: Design & conduct of clinical research

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. A. Prescriptions That Require Prior Authorization

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. A. Prescriptions That Require Prior Authorization

BRISTOL-MYERS SQUIBB and PFIZER/DIRECTOR v BAYER

Hot Line Session at European Society of Cardiology (ESC) Congress 2014:

Case 2:15-cv Document 1 Filed 04/29/15 Page 1 of 46 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA

Investor News. Not intended for U.S. and UK media

ORAL ANTICOAGULANTS - RIVAROXABAN (XARELTO) FOR DEEP VEIN THROMBOSIS (DVT)

CV ,Nt Jo. -against- Plaintiff,

New Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013

Considerations in Choosing Counsel for Multidistrict Litigation Cases and Mass Tort Cases

Breadth of indications matters One drug for multiple indications

New Real-World Evidence Reaffirms Low Major Bleeding Rates for Bayer s Xarelto in Patients with Non-Valvular Atrial Fibrillation

Updates to the Alberta Human Services Drug Benefit Supplement

Prior Authorization Guideline

Out with the Old and in with the New? Target Specific Anticoagulants for Atrial Fibrillation

ABOUT XARELTO CLINICAL STUDIES

EMA Reaffirms Positive Benefit-Risk Balance of Bayer s Xarelto for Stroke Prevention in Patients with Atrial Fibrillation

UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION

T-1 PROJECT DESCRIPTION VICINITY MAP CODE COMPLIANCE PROJECT INFORMATION DRIVING DIRECTIONS SHEET INDEX APPROVAL SITE LOCATION

Bayer Pharma AG Berlin Germany Tel News Release. Not intended for U.S. and UK Media

If You Paid for Vioxx Before October 1, 2004,

Updates to the Alberta Drug Benefit List. Effective January 1, 2016

JOINT COMPLAINT REVISED DRAFT (JANUARY, 2016)

LEvy mj FILED. -against- INC., BAYER HEALTHCARE PHARMACEUTICALS, INC., BAYER PHARMA AG, BAYER CORPORATION, BAYER HEALTHCARE LLC, BAYER HEALTHCARE AG,

Newer Anticoagulants and Newer Diabetic Drug Classes. Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013

Bayer Initiates Rivaroxaban Phase III Study to Support Dose Selection According to Individual Benefit-Risk Profile in Long- Term VTE Prevention

Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation

Anticoagulants for stroke prevention in atrial fibrillation Patient frequently asked questions

CLAIM FORM FOR ALLEGED PERSONAL INJURY. TIER II Non-Fatal Cardiac Arrest or TIER III Primary Tachycardic Ventricular Arrhythmia

Case 2:09-cv AJM-KWR Document 19 Filed 02/10/10 Page 1 of 7 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA

Removal to Federal Court - The New Rules Making it a Federal Case: New Developments Presented by Kevin Schiferl Frost Brown Todd (Indianapolis, IN)

Bayer Extends Clinical Investigation of Xarelto for the Prevention and Treatment of Life-Threatening Blood Clots in Patients with Cancer

Cardiovascular Disease

Case 3:15-cv MAS-DEA Document 1 Filed 04/20/15 Page 1 of 38 PageID: 1

Claims & Litigation Overview

Review of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain

Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical

Claims & Litigation Overview

Amy S. Harris Shareholder

Failure or significant adverse effects to all of the alternatives: Eliquis and Xarelto

How To Get A Dose Of Bayer Healthcare'S Oral Anticoagulant, Xarelto

2. Background This indication of rivaroxaban had not previously been considered by the PBAC.

Recent Developments in the Law & Technology Relating to Predictive Coding

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors

The Role of the Newer Anticoagulants

Case OHS/1:14-cv Document 8-1 Filed 11/02/14 Page 1 of 20 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION

Case 2:04-cv SRD-ALC Document 29 Filed 08/22/06 Page 1 of 5 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NO:

Committee Approval Date: September 12, 2014 Next Review Date: September 2015

Birmingham, Sandwell and Solihull Cardiac and Stroke Network. Rivaroxaban or warfarin for treatment of Atrial Fibrillation: Position statement

Antiplatelet and Antithrombotic Therapy. Dr Curry Grant Stroke Prevention Clinic Quinte Health Care

4/9/2015. Risk Stratify Our Patients. Stroke Risk in AF: CHADS2 Scoring system JAMA 2001; 285:

Medical Litigation in 2012

Bridging the Gap: How to Transition from the NOACs to Warfarin

Appendix I: Select Federal Legislative. Proposals Addressing Compensation for Asbestos-Related Harms or Death

Case 2:16-cv Document 1 Filed 03/22/16 Page 1 of 54 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA

Case 1:14-cv Document 1 Filed 11/04/14 Page 1 of 46 PageID #: 1 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK

Case 2:14-cv cr Document 1 Filed 07/25/14 Page 1 of 54

CV AND DEMAND. OCK j"' FiledpitEla Page 1 of 47 PagelD 1 IN CLERK'S OFFICE U 5-DISTRICT COURT EDICY SCANLON, M.J.

Case 2:14-cv MBN Document 91 Filed 08/25/15 Page 1 of 6 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NUMBER:

Case 2:05-cv HGB-ALC Document 342 Filed 07/14/08 Page 1 of 5 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NO.

LEGAL NOTICE THIS NOTICE MAY AFFECT YOUR RIGHTS; PLEASE READ CAREFULLY

Atrial Fibrillation. Gibtsawit Kidane Kimberly Pullen Jennifer Smith

HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below

Case 8:10-ml JVS-FMO Document 4713 Filed 10/17/14 Page 1 of 10 Page ID #:151279

Thrombosis and Hemostasis

The importance of adherence and persistence: The advantages of once-daily dosing

CAUSE NO. PLAINTIFF S ORIGINAL PETITION. Greg Abbott, and complains of OLD UNITED LIFE INSURANCE COMPANY ( Defendant ), and I.

Prescriber Guide. 20mg. 15mg. Simply Protecting More Patients. Simply Protecting More Patients

The Anti coagulated Patient: The Cardiologist s View. February 28, 2015

Title of Guideline. Thrombosis Pharmacist)

3/3/2015. Patrick Cobb, MD, FACP March 2015

Objectives. Patient Background. Transitioning a Patient To & From a New Oral Anticoagulant

CDEC FINAL RECOMMENDATION

ORAL ANTICOAGULANTS - RIVAROXABAN (XARELTO) FOR ATRIAL FIBRILLATION

Patient frequently asked questions

Personal Injury Litigation

Bayer Extends Clinical Investigation of Rivaroxaban into Important Areas of Unmet Medical Need in Arterial Thromboembolism

How To Treat Aneuricaagulation

Case 2:09-md EEF-JCW Document Filed 01/22/13 Page 1 of 7

Section 2 Day Forward Major Jury Program

Sudden dizziness, trouble walking, loss of balance or coordination

Investor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S.

Three new/novel oral anticoagulants (NOAC) have been licensed in Ireland since 2008:

Case 2:13-cv ILRL-KWR Document 31 Filed 02/26/14 Page 1 of 6 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NO.

Case 1:14-md JMF Document 70 Filed 07/18/14 Page 1 of 6

Product Liability. Leadership. R. Bruce Duffield

TSOAC Initiation Checklist

New Oral Anticoagulants

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF WISCONSIN

Transcription:

Case 2:14-md-02592-EEF-MBN Document 1785 Filed 12/17/15 Page 1 of 5 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA IN RE: XARELTO (RIVAROXABAN) * MDL NO. 2592 PRODUCTS LIABILITY LITIGATION * * SECTION L * * JUDGE ELDON E. FALLON * * MAG. JUDGE NORTH * * * * * * * * * * * * * * * * * * * * * * THIS DOCUMENT RELATES TO ALL CASES CASE MANAGEMENT ORDER NO. 4 (Bellwether Discovery Pool Selection Process and Eligibility Criteria) This Order shall govern the criteria for and selection of 40 discovery pool plaintiffs as stated in Case Management Order No. 3. I. Selection Process Requirements 1. Eligibility for the Discovery Pool. The parties have agreed upon the eligibility requirements and substantive categories for the discovery pool plaintiffs as set forth in Section II below. 2. Classification of Alleged Events. Each case will be classified based on the most serious event alleged by plaintiff in the Plaintiff Fact Sheet ( PFS ). For example, a plaintiff who alleges both a brain bleed and a nosebleed would be classified as a case involving an alleged brain bleed. Similarly, a plaintiff who alleges a gastrointestinal bleed, rectal bleed and nosebleed would be categorized as an alleged gastrointestinal bleed case.

Case 2:14-md-02592-EEF-MBN Document 1785 Filed 12/17/15 Page 2 of 5 3. Population of the Discovery Pool using MDL Centrality. By December 18, 2015, Brown Greer will identify eligible cases using the categories agreed upon by the parties and the geographic definitions in CMO 3 for the Eastern District of Louisiana, Mississippi and Texas and circulate to the parties arrays identifying same. (b) By December 23, 2015, the Plaintiffs and Defendants (collectively) must submit their suggested corrections, if any, to the Brown Greer arrays for the Eastern District of Louisiana, Mississippi and Texas. The parties are to meet and confer on the suggested corrections by January10, 2016. To the extent the parties are unable to agree on the corrections, the matter shall be brought to the attention of the Court and the Court shall enter an order at an appropriate time. (c) By December 31, 2015, Brown Greer will identify eligible cases using the categories agreed upon by the parties for all states having 20 or more properly venued plaintiffs, excluding Mississippi, Texas, and the Eastern District of Louisiana, and circulate to the parties arrays identifying same. (d) By January 5, 2016, the parties will simultaneously exchange their respective lists of four states that will be part of the random selection process. (e) By January 8, 2016, the Plaintiffs and Defendants (collectively) will submit suggested corrections, if any, to the BrownGreer arrays. The parties are to meet and confer on the suggested corrections by January10, 2016. To the extent the parties are unable to agree on the corrections, the matter shall be brought to the attention of the Court and the Court shall enter an order at an appropriate time. 4. Party Selections. By January 11, 2016, the Parties will make their selections from the categories below based on the arrays prepared by BrownGreer. The PSC and

Case 2:14-md-02592-EEF-MBN Document 1785 Filed 12/17/15 Page 3 of 5 Defendants (collectively) will each select 5 plaintiffs properly venued in the Eastern District of Louisiana, 1 plaintiff properly venued in Mississippi, 1 plaintiff properly venued in Texas and 1 plaintiff properly venued in each of three other states selected by the party under CMO 3. The parties should endeavor to, but are not required to, pick at least one case from each category. 5. Random Selections. The party picks will be removed from the arrays prepared by BrownGreer, and the arrays will be combined by Brown Greer by January 13, 2016 into a single pool for each state in which random selections will be made: Eastern District of Louisiana, Mississippi and the 8 party selected states (4 each) where the parties selected a plaintiff. There will be a maximum of ten individual pools. So for example, the Eastern District of Louisiana pool would consist of all Eastern District of Louisiana plaintiffs from all six categories. (b) The random selections will then be made by January 15, 2016: 10 plaintiffs from Louisiana, 2 from Mississippi, and 1 each from the other 8 states. 6. Challenges. Any challenges as permitted under CMO 3 to the random selections will be made by January 20, 2016. II. Eligibility and Substantive Categories for Discovery Pool Selection 1. General Requirements of All Selected Cases. Only those plaintiffs who have met the core requirements for the Plaintiff Fact Sheet ( PFS ) are eligible for selection in the discovery pool. Plaintiffs who had a demonstrable core deficiency as of December 15, 2015 will

Case 2:14-md-02592-EEF-MBN Document 1785 Filed 12/17/15 Page 4 of 5 not be included in the pool. The PFS must indicate that the plaintiff alleges a bleeding injury and/or death due to the bleeding injury. 2. Categories. To be eligible for the discovery pool, plaintiffs must satisfy all of the criteria in one of the categories below: embolism due to nonvalvular atrial fibrillation and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 50 and 90 at the date of the alleged event. (b) embolism (PE) and/or to reduce the risk of recurrence of DVT or PE and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 40 and 80 at the date of the alleged event. (c) embolism due to nonvalvular atrial fibrillation and alleges rectal bleeding or death due to rectal bleeding and was between the ages of 50 and 90 at the date of the alleged event. (d) embolism (PE) and/or to reduce the risk of recurrence of DVT or PE and alleges rectal bleeding or death due to rectal bleeding and was between the ages of 40 and 80 at the date of the alleged event. (e) embolism due to nonvalvular atrial fibrillation and alleges a brain bleed/hemorrhagic stroke or death due to a brain bleed/hemorrhagic stroke and was between the ages of 50 and 90 at the date of the alleged event.

Case 2:14-md-02592-EEF-MBN Document 1785 Filed 12/17/15 Page 5 of 5 (f) embolism (PE) and/or to reduce the risk of recurrence of DVT or PE and alleges a brain bleed/hemorrhagic stroke or death due to a brain bleed/hemorrhagic stroke and was between the ages of 40 and 80 at the date of the alleged event. New Orleans, Louisiana, on this day of December 2015. Judge Eldon E. Fallon United States District Court Judge