An Update on Xarelto Mass Tort Litigation

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

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