Product News and Recalls

Bayer Begins Facing Xarelto Lawsuits

Bayer facing lawsuits over XareltoBayer AG, a large German pharmaceutical company, is facing its first lawsuits in the United States over its anti-clotting drug Xarelto. A June 14 article reported that there are fewer than 10 Xarelto lawsuits currently filed.

In July 2011, the FDA approved Xarelto to prevent deep vein thrombosis in patients having knee or hip replacement surgery. In November 2012, the drug was approved to prevent pulmonary embolisms. In 2013, Xarelto had sales of $1.3 billion and is predicted sales could reach around $4.75 billion. The drugs Xarelto and Pradaxa have been taking over the anticoagulant market based on convenience, replacing an older blood thinner, warfarin.

In 2011 and 2012, Xarelto, Pradaxa, and warfarin were the most frequently referenced anticoagulants in adverse event reports to the FDA. There were 582 reported deaths from Pradaxa, 151 from Xarelto, and 56 from warfarin. In Germany in 2013, there were 968 reported adverse events from Xarelto, including 72 deaths. As these new anticoagulants become more popular, more and more side effects from the drug are beginning to be reported. Xarelto has been linked to increased risks of thrombotic events like strokes or blood clots, serious or fatal bleeding episodes, and gastrointestinal bleeding.

Another anticoagulant manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc., recently agreed to settle Pradaxa lawsuits filed against it, and will pay $650 million to approximately 4,000 injured plaintiffs. The lawsuits claimed that Pradaxa caused severe and sometimes fatal bleeding in patients.

If you have suffered injury due to a pharmaceutical or medical device, do not hesitate to contact Lopez McHugh for a free consultation today.