Xarelto Lawsuit

Reuter’s News reported in June of 2014 that Bayer AG had admitted to facing up to ten lawsuits in the U.S. regarding bleeding events caused by Xarelto.  Bayer and Johnson & Johnson have not released any specifics or news regarding potential settlements.

Three known lawsuits include:

  • A lawsuit filed in February of 2014 in the Pennsylvania Court of Common Pleas, Philadelphia County on behalf of a Kentucky patient who claims to have developed uncontrolled subdural (brain) bleeding after taking Xarelto.
  • A lawsuit filed June of 2014 against Johnson & Johnson and Bayer in the U.S. District Court for the Southern District of Florida.  The suit was filed by the wife of a patient who experienced uncontrolled bleeding and died following Xarelto use.
  • A lawsuit filed July 25, 2014 in the U.S. District Court for the District of Vermont by the family of a man who died following uncontrolled brain bleeding.  The bleeding episode occurred only 10 days after the patient began taking Xarelto.

Lawyers for the plaintiffs claim that the companies (Bayer and Johnson & Johnson) withheld warnings and information from both consumers and healthcare professionals about the risks of Xarelto.  They also claim that the companies did not adequately warn of the lack of antidote and about the lack of dosage adjustment.  Many additional lawsuits are expected.

More About Xarelto

Xarelto (rivaroxaban) is a newer type of blood thinning medication.  It was designed to replace older anti-coagulants such as warfarin (Coumadin) and works in a different way than other blood thinners.  It is manufactured by Bayer Healthcare, a division of the Bayer AG Company based in Germany.  In the U.S. it is marketed by Janssen Pharmaceuticals, a division of the medical products giant, Johnson & Johnson.

Xarelto was approved in 2011 and is used to treat blood clot formation in deep vein thrombosis (DVT) and pulmonary embolism (PE) and to prevent clot formation in patients with non-valve related atrial fibrillation, knee or hip replacement and those with DVT or PE.

As of the first quarter of 2013, Xarelto had serious adverse event reports being filed at a faster rate than any other novel anti-coagulant with nearly 700 during that time period.  The medication has reportedly caused a number of deaths and is the focus of multiple lawsuits regarding bleeding events.

The total anti-coagulant market is estimated at $10 billion annually and Xarelto sales were $1.3 billion in 2013 and may exceed $5 billion in 2014.  Johnson & Johnson had a worldwide revenue of $71 billion in 2013 and Bayer AG’s revenue was an estimated $54 billion.

Xarelto Side Effects and Drug Interactions

Xarelto, like most medications has a number of side effects and drug interactions.  Some of these side effects are minor but some are serious and may even become life threatening.

Xarelto may cause side effects which are usually not severe but may need medical treatment such as:

  • Nausea and vomiting
  • Headache
  • Low blood pressure
  • Dizziness
  • Muscle pain
  • Swelling

Xarelto may also interact with a number of medications and require dosage adjustment such as:

  • Anti-infectives including antibiotics, antifungals and antivirals
  • Anti-convulsants
  • Anti-inflammatory medications including aspirin and NSAIDs
  • Herbal medications

In some cases, side effects that seem minor may indicate a much more severe problem.  A healthcare practitioner should be informed about any side effects that appear to be related to Xarelto or any symptoms of bleeding which may indicate a medical emergency.

Severe Adverse Events of Xarelto

Xarelto may cause severe side effects which are related to an inability to clot.  Xarelto is different from other anti-coagulants as laboratory testing is not done to individualize treatment and there is no antidote to treat episodes of Xarelto related bleeding.

Severe bleeding episodes have resulted in death after some patients have taken the medication.  Prescribing information of Xarelto includes a black-box warning about the risk of spinal bleeding after spinal procedures or trauma which may result in long-term or permanent paralysis.

Elderly patients are also at an increased risk of cranial bleeding which may cause severe disability or death and are more likely to develop uncontrolled bleeding because of a fall.

Any symptoms of bleeding should be reported immediately to a healthcare professional such as:

  • Extreme fatigue or dizziness
  • Pale skin
  • Abdominal swelling
  • Easy or unexplained bruising
  • Tarry stool
  • Rectal, Urinary or Genital bleeding
  • Eye or Nose bleeding
  • Sudden or extreme pain which is unexplainable
  • Loss of consciousness or stroke symptoms

Uncontrolled bleeding may threaten essential organs such as the brain, lungs, liver or kidneys and may become life-threatening.  Bleeding caused by Xarelto use cannot be easily reversed as there is no antidote and dosages are not adjusted to patient characteristics such as weight, age or medical health.

Incorrect Dosing Information of Xarelto

The Xarelto website for healthcare professionals included incorrect dosing information which was reportedly corrected by March 19, 2014.  In June of 2014, a letter warning healthcare professionals of the error and outlining the correct dosing information was issued by Janssen Pharmaceuticals.   It is not known if the incorrect information published on the website caused any adverse effects.

View Sources
  1. Chang, P. (June 2014) Healthcare professionals letter: Correction of Dosing Information for Xarelto Tablets, Janssen Pharmaceuticals, Accessed on 01 August 2014, www.xareltohcp.com/sites/default/files/pdf/HCP-Dosing-Correction-Letter.pdf
  2. Food and Drug Administration (01 July 2011) FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery. [Press release] U.S. Food and Drug Administration.. Accessed on 01 August 2014 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261839.htm
  3. Food and Drug Administration (04 November 2011). FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm [Press release] U.S. Food and Drug Administration.. Accessed on 01 August 2014 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278646.htm
  4. Food and Drug Administration (02 November 2012). FDA expands use of Xarelto to treat, reduce recurrence of blood clots. [Press release] U.S. Food and Drug Administration.. Accessed on 01 August 2014 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326654.htm
  5. Institute for Safe Medicine Practices, (May 2014) QuarterWatch 2013 Q1, ISMP, Accessed on 01 August 2014, http://www.ismp.org/quarterwatch/
  6. Nguyen, A. (29 May 2012), Advisory panel recommends against anticoagulant drug approval. Wolters Kluwer Law and Health. Accessed on 01 August 2014 http://health.wolterskluwerlb.com/2012/05/advisory-panel-recommends-against-anticoagulant-drug-approval/
  7. Pierson, R. (14 June 2012) Insight: Top heart doctors fret over new blood thinners. Reuters. Accessed on 01 August 2014 http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614
  8. Palmer, E. (16 June 2014) Sources: Bayer, J&J's Xarelto faces first U.S. lawsuits, FiercePharma, Accessed on 01 August 2014 http://www.fiercepharma.com/story/sources-bayer-jjs-xarelto-faces-first-us-lawsuits/2014-06-16
  9. PR Web, (27 July 2014) Xarelto Lawsuit News: Report Finds Adverse Events For Xarelto Bleeding Side-Effects Outnumber Those For Pradaxa, Accessed on 01 August 2014 http://www.12newsnow.com/story/26122518/xarelto-lawsuit-news-report-finds-adverse-events-for-xarelto-bleeding-side-effects-outnumber-those-for-pradaxa
  10. PRWeb.com, (30 July 2014),Xarelto Lawsuit Alleges Man's Death from Uncontrollable Brain Bleeding Was Caused by Xarelto, Digital Journal, Accessed on 01 August 2014 http://www.digitaljournal.com/pr/2090599
  11. PRWeb.com (17 July 2014), Xarelto is Alleged to Cause Serious and Uncontrolled Internal Bleeding, NewsWest 9, Accessed on 01 August 2014 http://www.newswest9.com/story/26043658/xarelto-is-alleged-to-cause-serious-and-uncontrolled-internal-bleeding
  12. Reuters (14 June 2014)Bayer faces law suits in United States over Xarelto: paper, Reuters Frankfurt, Accessed on 01 August 2014 http://www.reuters.com/article/2014/06/14/us-bayer-suit-idUSKBN0EP0HW20140614
  13. Xarelto Consumer Information (2014). Janssen Pharmaceuticals, Accessed on 01 August 2014 https://www.xarelto-us.com/
  14. Xarelto Professionals (2014), Janssen Pharmaceuticals, Accessed on 01 August 2014, http://www.xareltohcp.com/
  15. Xarelto Prescribing Information, (2014), Janssen Pharmaceuticals, Accessed on 01 August 2014 www.xareltohcp.com/prescribing-information.pdf