XARELTO (RIVAROXABAN) has been linked to fatalities and serious side effects here is why there are a growing number of lawsuits nationwide https://www.linkedin.com/pulse/20140827205752-21826356-xarelto-fatalities-deaths-side-effects-and-growing-market-share-as-lawsuits-mount
7. 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
9. 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
11. 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
12. • Age increases risk
• Heart Disease
• High Blood Pressure
• Family History
• Obesity
• Alcohol Use - Binge Drinking
• Chronic Conditions
Risk Factors for AFib
13. • Diagnosis may involve several tests
• Electrocariodgram (ECG)
• Portable ECG or Holter Monitor over period of time
• Echocardiogram
• Blood Tests
AFib Diagnosis
14. • Damage to the Heart
• Heart Attacks
• Coronary Artery Disease
• Abnormal HeartValves
• High Blood Pressure
• Congenital Heart Defecs
• Metabolic Imbalance
• Viral Infections
• Lung Disease
• Prior Heart Surgery
• Sleep Apnea
• Stress Illness, Surgery or Pneumonia
Potential Causes
15. • 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 ofVitamin 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
16. 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
19. • 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. - NewYork, NY
Novel Anticoagulants
Fueled By Race to Market
20. PRADAXA
1st Novel Anticoagulant inYears
• Parallel Marketing Themes
• No Monitoring
• No Dietary Restrictions
• Lifestyle Message like birth control
21. XARELTO -
Market Share
Heir Apparent
• Parallel Marketing Themes
• No Monitoring
• No Dietary Restrictions
• Lifestyle
22. 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
35. XARELTO MDL NO. 2592
IN 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
38. Multi-Count Complaint
• Count I - Strict Liability
• Count II - Manufacturing Defect
• Count III - Design Defect
• Count IV - Failure To Warn
• CountV - Negligence
• CountVI - Breach of Express Warranty
• CountVII - Breach of Implied Warranty
• CountVIII - 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
39. • 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
51. 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