Yet another civil action was filed in the U.S. District Court for the Eastern District of Louisiana against the developers, manufacturers, and promoters of Xarelto, a high revenue-producing anticoagulant drug also known as rivaroxaban.

On May 10, 2017, plaintiff Elton G. brought a Xarelto life-threatening bleeding lawsuit against Janssen Research and Development LLC, Janssen Pharmaceuticals Inc., Janssen Ortho LLC, Bayer Healthcare Pharmaceuticals Inc, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare AG, Bayer Pharma, and Bayer AG (the defendants).

Elton G. experienced Xarelto life-threatening bleeding in late May 2015, after taking the anticoagulant for five months as prescribed by her doctor.  According to the plaintiff, the bleeding episode induced anemia and other permanent injury.

She alleges the episode also caused the plaintiff to incur excessive financial liabilities for hospitalization, inpatient and follow-up outpatient care. She claims to have suffered mental and emotional trauma because of alleged negligence on the part of the defendants.

What is Xarelto?

Xarelto or rivaroxaban was approved by the Food and Drug Administration (FDA) on July 1, 2011 for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in patients referred for total hip or knee replacement surgeries.

DVT and PE are serious blood clots which can cause local tissue death, cardiac and/or respiratory arrest, and stroke.  They are very common in the recovery phase of these types of surgeries.

By November of the same year, Xarelto received additional approval for use in embolism (blood clot) and stroke risk reduction in patients with non-valvular atrial fibrillation.

Xarelto Achieves Blockbuster Status

Through the aggressive marketing campaign of the defendants, Xarelto achieved what is known as ‘blockbuster’ status in the pharmaceutical industry by the end of 2013. In industry terms, a blockbuster drug means it has cleared over $1 billion dollars in sales revenue.

Plaintiff Says Defendants Ignore Negative, Promote the Positive

According to Elton G. in this Xarelto life-threatening bleeding lawsuit, the defendants chose to focus on merely the positive aspects of pre-marketing testing and ignore red safety flags that came up during the same process.

On the positive side, Xarelto was proven superior to another commonly-used anticoagulant in preventing DVT and PE post-joint replacement.  On the negative side, Xarelto proved to have a greater incidence of bleeding and decreased hemoglobin levels that then required blood transfusion.

Another study focused on the drug’s use with non-valvular atrial fibrillation noted that although it didn’t function in a poorer manner when compared with the commonly-used anticoagulant, bleeding in upper and lower gastrointestinal sites happened more often.

Plaintiff: Aggressive Promotion of Xarelto Ignores Serious Adverse Events

According to the facts as listed in the lawsuit, at the end of 2012, Xarelto had 2,081 new serious adverse events (SAE) associated with its use filed with the FDA. Of those 2,081 events, 151 people died.

This figure was three times the amount of deaths reported with the use of warfarin, an anticoagulant in use for up to 60 years. This data was ignored by defendants in all promotional materials and there was not even a black box or bolded warning added to the label until required by the FDA at a much later date.

Elton G. is bringing several counts against the defendants in this Xarelto life-threatening bleeding lawsuit including negligence, failure to warn, and products liability to name just a few.

Elton’s Xarelto Lawsuit is Case No. 2:17-cv-04836 in the U.S. District Court for the Eastern District of Louisiana.