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XARELTO
(rivaroxaban)
Update on XARELTO
Mass Tort Litigation
June 23, 2015
Webinar Sponsor
gabe@pathtojustice.com
Why Anticoagulants?
• Blood Thinners make the blood “thinner” and inhibit clotting
• Blood clots can block blood vessels l...
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 ...
http://www.mayoclinic.org/
Atrial Fibrillation
• Irregular heart beat where heart’s upper
chambers (Atria) are out of sync with
lower chambers (Ventr...
• Age increases risk
• Heart Disease
• High Blood Pressure
• Family History
• Obesity
• Alcohol Use - Binge Drinking
• Chr...
• Diagnosis may involve several tests
• Electrocariodgram (ECG)
• Portable ECG or Holter Monitor over period of time
• Ech...
• Damage to the Heart
• Heart Attacks
• Coronary Artery Disease
• Abnormal HeartValves
• High Blood Pressure
• Congenital ...
• WARFARIN/COUMADIN (also known
as Jantoven, Marevan and Uniwarfin)
used as anticoagulant since the 1950’s
• Originally int...
Emergent Solution - Antidote
• Reversal Agent is known
• There is a Known and Time Proven Antidote
• Fresh Frozen Plasma
•...
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)
• Ja...
PRADAXA
1st Novel Anticoagulant inYears
• Parallel Marketing Themes
• No Monitoring
• No Dietary Restrictions
• Lifestyle ...
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 Investig...
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. 2592
IN RE: XARELTO (RIVAROXABAN)
PRODUCTS LIABILITY LITIGATION
• JPML Transfer Order 12/12/14
• United St...
http://www.laed.uscourts.gov/Xarelto/Orders/Orders.htm
• Pre-Trial Orders
• Direct Filing
• Joint Complaints
• Plaintiff F...
Defendants
Multi-Count Complaint
• Count I - Strict Liability
• Count II - Manufacturing Defect
• Count III - Design Defect
• Count I...
• Serious bleeding events and some
XARELTO Fatalities
• 2,081 SAE MedWatch Reports with FDA
in 2012
• Likely underreported...
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...
Case Acquisition
• Traditional sources:
• TV, Print, Radio & Web
• Referrals
• Co-counsel
• Neighbors (Literally)
• Friend...
gabe@pathtojustice.com
gabe@pathtojustice.com
gabe@pathtojustice.com
July 27, 2015 - Risperdal Webinar
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
An Update on Xarelto Mass Tort Litigation
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An Update on Xarelto Mass Tort Litigation

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Presenter: Gabe Zambrano of Farmer, Jaffe, Weissing, Edwards, Fistos & Lehrman, P.L. in Ft. Lauderdale, FL. He is spearheading the investigation of side effects associated with Xarelto.

register now NTL webinarMr. Zambrano served as co-counsel in an Engle Tobacco trial in 2011 that resulted in one of the largest reported verdicts that year. Today, he advocates for victims of personal injuries, and develops mass tort projects where patients suffer injuries from drugs or pharmaceutical devices, including Yasmin, Mirena IUD, Pradaxa, and Nuvaring Vaginal Ring. He continues to speak at national conferences and organizational meetings making him available to aid victims across the United States through co-counsel relationships in multiple jurisdictions.

Xarelto
Worldwide more than 7 million people have been prescribed Xarelto.

What is Xarelto?

Xarelto is a prescription medication used to treat patients with atrial fibrillation, or AFib, not caused by a heart valve problem. Atrial Fibrillation is a heart condition that causes blood to pool in the upper chambers of the heart and increases the chance of a stroke or blood clot.

In the United States, Xarelto has also been approved to treat blood clots in the legs (deep vein thrombosis) and in the lungs (pulmonary embolism).

Hundreds of deaths

In September 2013, reports emerged in Germany that Xarelto had been linked to 968 side effect reports, which included 58 deaths, with German drug regulators.

According to US lawsuits, hundreds of patients died because of bleeding caused by the drug. In 2012, the FDA reported that three times more people died from adverse events while on Xarelto compared to Warfarin.

In addition, while it is supposed to prevent blood clots, the Food and Drug Administration (FDA) has already received reports of dangerous blood clots in people taking the drug.

The number of potential deaths in the US are not known because the adverse event reporting system is a volunteer system. However, it is known that in combination, Xarelto, Pradaxa and Warfarin or Coumadin have been linked to 789 deaths in 2013.

Published in: Law
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An Update on Xarelto Mass Tort Litigation

  1. 1. XARELTO (rivaroxaban) Update on XARELTO Mass Tort Litigation June 23, 2015
  2. 2. Webinar Sponsor
  3. 3. gabe@pathtojustice.com
  4. 4. 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
  5. 5. http://www.heart.org/idc/groups/heart-public/@wcm/@hcm/ documents/downloadable/ucm_300338.pdf
  6. 6. 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
  7. 7. http://www.mayoclinic.org/
  8. 8. 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
  9. 9. • Age increases risk • Heart Disease • High Blood Pressure • Family History • Obesity • Alcohol Use - Binge Drinking • Chronic Conditions Risk Factors for AFib
  10. 10. • Diagnosis may involve several tests • Electrocariodgram (ECG) • Portable ECG or Holter Monitor over period of time • Echocardiogram • Blood Tests AFib Diagnosis
  11. 11. • 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
  12. 12. • 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
  13. 13. 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
  14. 14. New Oral Anticoagulants - NOACs Marketing Message & Appeal For the Masses
  15. 15. New & Improved - One Dose Fits All
  16. 16. • 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
  17. 17. PRADAXA 1st Novel Anticoagulant inYears • Parallel Marketing Themes • No Monitoring • No Dietary Restrictions • Lifestyle Message like birth control
  18. 18. XARELTO - Market Share Heir Apparent • Parallel Marketing Themes • No Monitoring • No Dietary Restrictions • Lifestyle
  19. 19. 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
  20. 20. January/February 2013 - WebMd Magazine
  21. 21. June 6, 2013 - Untitled FDA Letter
  22. 22. http://www.bmj.com/content/349/bmj.g4670.full.pdf+html July 2014
  23. 23. August 2014
  24. 24. Broad Base of Indications
  25. 25. Prescribing Information - Major Changes
  26. 26. 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
  27. 27. 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
  28. 28. Defendants
  29. 29. 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
  30. 30. • 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
  31. 31. Appoints PSC Leadership
  32. 32. XARELTO - Philadelphia, PA
  33. 33. CNN - Ad 2015
  34. 34. 2015
  35. 35. May 2015 - Paid Search
  36. 36. http://www.fiercepharmamarketing.com/story/should-eliquis-surge-make-xarelto- fans-very-very-afraid-not-really-analyst/2015-05-18 May 18, 2015
  37. 37. 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
  38. 38. gabe@pathtojustice.com
  39. 39. gabe@pathtojustice.com
  40. 40. gabe@pathtojustice.com
  41. 41. July 27, 2015 - Risperdal Webinar

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