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XARELTO(rivaroxaban)
Update on XARELTO Mass Tort Litigation
June 23, 2015
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Why Anticoagulants?• Blood Thinners make the blood “thinner” and inhibit clotting
• Blood clots can block blood vessels leading to strokes or heart attacks
• Blood clots can travel to lungs (emboli) or legs (deep vein thrombosis)
• Clotting occurs through a complicated process
• Post-Surgery blood clots can lead to complications including Deep Vein Thrombosis (DVT) Pulmonary Emboli (PE) from reduced activity during recuperation
http://www.heart.org/idc/groups/heart-public/@wcm/@hcm/documents/downloadable/ucm_300338.pdf
Natural Clotting• Natural clotting is necessary to stop bleeding but a medical pre-disposition to
clotting can present a health problem or lead to medical complications
• Post-Operative blood clots can prove fatal and why they get you up and moving as soon as possible after surgery
• Added Risk Factors of Age, Obesity, Heart Disease set the table for a Perfect Storm or Medical Cascade of Problems
http://www.mayoclinic.org/
Atrial Fibrillation
• Irregular heart beat where heart’s upper chambers (Atria) are out of sync with lower chambers (Ventricles)
• Undetected or Untreated it can lead to blood clots and complications from blood clots traveling to other organs or parts of the body
• Age increases risk
• Heart Disease
• High Blood Pressure
• Family History
• Obesity
• Alcohol Use - Binge Drinking
• Chronic Conditions
Risk Factors for AFib
• Diagnosis may involve several tests
• Electrocariodgram (ECG)
• Portable ECG or Holter Monitor over period of time
• Echocardiogram
• Blood Tests
AFib Diagnosis
• Damage to the Heart
• Heart Attacks
• Coronary Artery Disease
• Abnormal Heart Valves
• High Blood Pressure
• Congenital Heart Defecs
• Metabolic Imbalance
• Viral Infections
• Lung Disease
• Prior Heart Surgery
• Sleep Apnea
• Stress Illness, Surgery or Pneumonia
Potential Causes
• WARFARIN/COUMADIN (also known as Jantoven, Marevan and Uniwarfin) used as anticoagulant since the 1950’s
• Originally introduced in late 1940’s as rat poison or pesticide
• Remains a widely prescribed and popular anticoagulant
• Onset of anticoagulant qualities is not immediate
• Known to Interact with other common medications
• Requires dietary restrictions because it interacts with leafy foods or greens with large amounts of Vitamin K
• Requires regular or routine blood test monitoring to maintain therapeutic range of dose
• INR (International Normalized Ratio) Too High = Risk of Bleeding Too Low = Risk of Blood Clot
• Therapeutic Range - Balancing Act
• Risk of Hemorrhage/Bleeding Exists
Historical Backstory
Emergent Solution - Antidote
• Reversal Agent is known
• There is a Known and Time Proven Antidote
• Fresh Frozen Plasma
• Vitamin K with Prothrombin Complex Concentrate
• Vitamin K Intravenously
New Oral Anticoagulants - NOACs
Marketing Message & Appeal For the Masses
New & Improved - One Dose Fits All
• PRADAXA (dabigatran etexilate)
• Boehringer Ingelheim Pharmaceuticals, Inc. - Ridgefield, CT
• XARELTO (rivaroxaban)
• Janssen Pharmaceuticals, Inc. - Titusville, NJ
• Bayer Healthcare AG - Leverkusen, Germany
• ELIQUIS (apixaban)
• Briston-Myers Squibb Company - Princeton, NJ
• COUMADIN - Registered Trademark Holder
• Pfizer Inc. - New York, NY
Novel Anticoagulants Fueled By Race to Market
PRADAXA 1st Novel Anticoagulant in Years
• Parallel Marketing Themes
• No Monitoring
• No Dietary Restrictions
• Lifestyle Message like birth control
XARELTO - Market Share Heir Apparent• Parallel Marketing Themes
• No Monitoring
• No Dietary Restrictions
• Lifestyle
Safety Signals & Red Flags• International Safety Signals - PRADAXA
• PRADAXA Litigation
• $650M Settlement
• BMJ Investigative Report on PRADAXA based on litigation records and information
• XARELTO
• July 1, 2011 - New Oral Anticoagulant (NOAC) DVT & PE post-op knee/hip
• November 4, 2011 - Non-valvular AFib
• FDA’s MedWatch
• U.S. Food & Drug Administration’s Adverse Event Reporting System (FAERS)
• Voluntary Reporting
• Companies Required to investigate those they learn about
• Cornerstone/Foundation
• Gaps in System
January/February 2013 - WebMd Magazine
June 6, 2013 - Untitled FDA Letter
http://www.bmj.com/content/349/bmj.g4670.full.pdf+html
July 2014
August 2014
Broad Base of Indications
Prescribing Information - Major Changes
XARELTO MDL NO. 2592IN RE: XARELTO (RIVAROXABAN) PRODUCTS LIABILITY LITIGATION
• JPML Transfer Order 12/12/14
• United States District Court Eastern District of Lousiana
• MDL No. 2592
• The Honorable Eldon E. Fallon
• Experienced, well versed in MDL with ability and willingness to manage case
• VIOXX; Chinese DryWall
• Magistrate Judge North
• Approximately 550+ cases with more anticipated
http://www.laed.uscourts.gov/Xarelto/Orders/Orders.htm
• Pre-Trial Orders
• Direct Filing
• Joint Complaints
• Plaintiff Fact Sheet
• Defendant Fact Sheet
• Science Day - June 2015
• Common Benefit Order - Pre-Trial Order No. 8
Defendants
Defendants
Multi-Count Complaint• Count I - Strict Liability
• Count II - Manufacturing Defect
• Count III - Design Defect
• Count IV - Failure To Warn
• Count V - Negligence
• Count VI - Breach of Express Warranty
• Count VII - Breach of Implied Warranty
• Count VIII - Negligent Misrepresentation
• Count IX - Fraud
• Count X - Violation of Consumer Protection Laws/Consumer Fraud Laws
• Count XI - Loss of Consortium
• Count XII - Wrongful Death
• Count XIII - Survival Action
• Count XIV - State Specific (ie. FL Total Permanent Impairment of Parent)
• Jury Trial Demand
• Serious bleeding events and some XARELTO Fatalities
• 2,081 SAE MedWatch Reports with FDA in 2012
• Likely underreported as system if voluntary not compulsory and notorious for blind spots
• At least 151 Deaths
• $2B in Sales in 2013
• RECORD Studies design flaw and in manner conducted
• “Systematic discarding of medical records” and thus unreliable P54
• ROCKET AF study compared to warfarin. Poorly managed group and made it look “non-inferior”
• Cases Filed in MDL growing over 500+
• Science Day was last week
• Document review underway
Appoints PSC Leadership
XARELTO - Philadelphia, PA
CNN - Ad 2015
2015
May 2015 - Paid Search
http://www.fiercepharmamarketing.com/story/should-eliquis-surge-make-xarelto-fans-very-very-afraid-not-really-analyst/2015-05-18
May 18, 2015
Case Acquisition• Traditional sources:
• TV, Print, Radio & Web
• Referrals
• Co-counsel
• Neighbors (Literally)
• Friends & Family
• Demographic & Illness Driven
• Screen carefully
• Proof of Use
• Latency/Onset
• Other Medications in Use
• Adverse Event or Side Effects being litigated
• Bleeding Events
• XARELTO Fatalities
• Gastrointestinal Bleeding
July 27, 2015 - Risperdal Webinar
