More than 18,000 patients have filed lawsuits alleging that the blood-thinning medication Xarelto caused them to suffer internal bleeding, the risk of which they allege was not disclosed to them. Johnson & Johnson and Bayer jointly developed Xarelto, which was approved by the FDA in 2011 to be used in patients undergoing hip and knee surgeries in order to prevent those patients from developing potentially fatal blood clots. The use of Xarelto was subsequently extended to patients who are at increased risk of stroke due to atrial fibrillation (an irregular heart beat).
Xarelto is big business for both Johnson & Johnson and Bayer. Xarelto reportedly was the top-selling drug for Bayer in 2016, responsible for $3.24 billion in sales (up from $2.5 billion in 2015). Xarelto is Johnson & Johnson’s third-best-selling drug, responsible for $2.29 billion in sales in 2016.
Xarelto patients have alleged in their pharmaceutical lawsuits that Xarelto was wrongly marketed as being more effective than Coumadin (warfarin) in preventing strokes and that Xarelto was easier for patients because they did not require routine blood tests, as required for patients taking Coumadin. Unlike for Coumadin, there is no antidote to reverse the blood-thinning effects of Xarelto.
Johnson & Johnson maintains in its defense to the Xarelto lawsuits that Xarelto has been approved by the FDA as safe and effective, based on years of data regarding the drug, and that adequate warnings regarding the risk of internal bleeding have been made.
On December 12, 2014, the United States Judicial Panel On Multidistrict Litigation (“Panel”) transferred pending federal Xarelto lawsuits to the Eastern District of Louisiana and assigned the Xarelto cases to the Honorable Eldon E. Fallon, for coordinated or consolidated pretrial proceedings with the actions pending there. The Panel found that the pending Xarelto actions “involve common questions of fact and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. These actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking Xarelto (rivaroxaban) and that defendants did not adequately warn prescribing physicians or consumers of the risks associated with Xarelto, including the potential for severe or fatal bleeding and the unavailability of a reversal agent to counteract Xarelto’s anticoagulation effects. Issues concerning the development, manufacture, regulatory approval, labeling, and marketing of Xarelto thus are common to all actions.”
The first of four federal Xarelto trials scheduled over the next several months is set to begin before Judge Fallon on May 1, 2017.
If you or a loved one suffered injuries (or worse) as a result of taking Xarelto or another drug in the United States, you should promptly seek the legal advice of a pharmaceutical claim lawyer in your state who may investigate your drug claim for you and represent you in a claim against a pharmaceutical company, if appropriate.
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