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Xarelto, one of a set of anticoagulant drugs known as Factor Xa inhibitors, has become the subject of a number of lawsuits due to the development of severe side effects, including the potential for unstoppable bleeding in as many as 15% of patients who take it. 1
The total number of lawsuits currently pending against Bayer and Johnson & Johnson over Xarelto is unknown.
Xarelto Multidistrict Litigation (MDL 2592)
In early October 2014, more than 20 patients and family members who had personally or whose loved ones had taken Xarelto asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer their cases to a new multidistrict litigation (MDL).
This transfer would help consolidate decisions about common facts in these cases under a single judge, while allowing the cases to move forward individually based on the unique circumstances for each lawsuit. 2
MDLs for Blood Thinners
In the past, MDLs have been created in similar cases related to anticoagulants like warfarin (MDL 1232), Heparin (MDL 1953), and Pradaxa (MDL 2385).
On December 4, 2014, the JPML heard oral arguments related to the request of an MDL for Xarelto. 3 On December 12, the panel ordered 21 different cases transferred to the Eastern District of Louisiana, where litigation for alleged Xarelto-related sickness and deaths would be centralized going forward. Other cases may be transferred into MDL 2592 as they are filed. 4
In the transfer order, the Panel specifically notes that the recent increase in Xarelto litigation requires a formal process for discovery and “other pretrial matters.”
FDA Cardiovascular and Renal Drugs Advisory Committee Evaluates Xarelto
In May 2012, the FDA Cardiovascular and Renal Drugs Advisory Committee met to discuss the possibility of expanding Xarelto’s labeled indications. At that meeting, the committee voted against approving the drug for new uses, highlighting that “they could not rely on the evidence” presented by Janssen Pharmaceuticals (a division of Johnson & Johnson). 5
Despite the agency’s hesitation over heavy bleeding and other serious conditions that could arise from taking Xarelto, the FDA eventually approved expanded uses of Xarelto in November 2012, referring to three studies of more than 9,000 individuals that allegedly show Xarelto to be safe for the treatment of pulmonary embolism and deep vein thrombosis. The FDA’s press release does not name the studies it relied on for this approval, and the agency acknowledged major bleeding was still a side effect of the anticoagulant drug. 6
- Institute for Safe Medication Practices. “Anticoagulant Update.” (May 7, 2014) Quarter Watch. Accessed Oct. 24, 2014.
- Justia Dockets & Filings. “IN RE: Xarelto Products Liability Litigation.” (Oct. 9, 2014) Justia.com. Accessed Dec. 17, 2014.
- U.S. Judicial Panel on Multidistrict Litigation. “Notice of Oral Argument Schedule December 4, 2014, Hearing Session.” (Filed Nov. 21, 2014) Accessed Dec. 17, 2014.
- U.S. Judicial Panel on Multidistrict Litigation. “In Re: Xarelto (Rivaroxaban) Products Liability Litigation – Transfer Order.” (Dec. 12, 2014) Accessed Dec. 17, 2014.
- U.S. Food & Drug Administration. “Summary Minutes of the Cardiovascular and Renal Drugs Advisory Committee.” (May 23, 2012) FDA.gov. Accessed Oct. 24, 2014.
- U.S. Food & Drug Administration. “FDA expands use of Xarelto to treat, reduce recurrence of blood clots.” (Nov. 8, 2012) FDA.gov. Accessed Oct. 25, 2014.