Product News and Recalls

Xarelto Bellwether Cases Inch Closer to Court Dates

more xarelto cases set for trialIn 2011, the FDA approved a drug that many hoped would be the first step forward in blood thinning medication since Coumadin’s debut in the 1960s: Xarelto.

Created by Johnson & Johnson and Bayer, Xarelto has been responsible for over $3.2 billion in profits for its manufacturers and developers. It has also become Bayer’s top-selling medication ever. Yet despite its successes on paper, the reality is that more than 18,000 plaintiffs have brought suit against the two companies claiming that Xarelto is “unreasonably dangerous,” according to Reuters.

Xarelto is prescribed for atrial fibrillation and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms. In other words, its primary purpose is to prevent blood clots that could eventually move to vital organs and cause severe injury or death. However, unlike Coumadin, a primary selling point for Xarelto is that it requires no blood tests prior to being prescribed.

Allegations assert that Xarelto can cause uncontrollable internal bleeding in some patients. This is most alarming because as of this writing there is no antidote to stop that bleeding once it starts. According to reports filed with the FDA, Xarelto may be responsible for over 370 patients bleeding to death, with no way of stopping that bleeding once it has started.

Other potential side effects of Xarelto can include unusual bleeding from the nose or gums; red, pink, or brown urine; bright red or black stools, headaches, dizziness, weakness, pain, swelling, and new drainage at wound sites. Patients may also cough up blood clots or have vomiting that resembles coffee grounds. FDA advises anyone who develops these symptoms to contact their doctor or medical professional immediately.

One such plaintiff, Joseph Boudreaux of Louisiana, exhibited even more extreme symptoms after starting a Xarelto prescription. He was hospitalized for a week in the intensive care unit as he endured multiple blood transfusions and heart procedures to keep him alive. Boudreaux regards the decision to start Xarelto as one of the biggest mistakes of his life.

The Journal of the American Medical Association’s Internal Medicine edition published a study that used real world data in comparing Xarelto to its major competitor, Pradaxa. Real world data is significant because it is much more difficult to manipulate than other data sets that can be used in a study. The study examined the records of 118,000 Medicare patients and concluded that those who took Xarelto showed a significantly higher likelihood of intracerebral hemorrhage and major extracranial bleeding, including major gastrointestinal bleeds.

A federal jury recently ruled in favor of Johnson & Johnson and Bayer in Boudreaux’s case, clearing the companies of failure to properly warn patients of the dangers of Xarelto. Boudreaux’s attorneys were disappointed but have stated that they’ll “continue to press forward with the legal claims of thousands of innocent victims whose lives have been shattered by” the drug. Additional bellwether cases are set to begin as early as the end of May.