A lawsuit claims that the blood thinner Xarelto can cause a dangerous gastrointestinal bleed.

Plaintiff Pamela M. claims that her late husband Hildred suffered a severe gastrointestinal bleed as a result of his use of Xarelto, a blood thinner. She claims that Bayer, the maker of the drug, and Johnson & Johnson’s family of companies, which were involved in the manufacture and research of the drug, knew or should have known of the fact that Xarelto could cause severe gastrointestinal bleeds in patients, but failed to warn patients and medical professionals of the risks.

Pamela states that Xarelto is an anticoagulant (blood thinner) primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism, and to prevent deep vein thrombosis and pulmonary embolism in patients going through hip and knee replacement surgery.

Pamela claims that Hildred took Xarelto between August 23, 2013 and December 26, 2013, and that as a result of his use of the drug, he suffered a severe gastrointestinal bleed. As a result, she claims that he suffered physical injury and suffering due to the bleed, financial injury due to medical bills and lost wages due to missed work, and emotional injury.

Pamela states that Xarelto was released into the American drug market on July 1, 2011 and is one of a class of blood thinners marketed as the “next generation of blood-thinning drugs” used to replace warfarin, which has long been one of the most common blood thinners on the market. Other drugs in this new class of blood thinners include Pradaxa and Eliquis.

Pamela alleges that the drugs received FDA approval based on insufficient testing of the drugs and their effects. She notes that the approval of the drugs was based on the results of a series of clinical trials called the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism studies (known as the RECORD studies), and the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation studies (known as ROCKET AF).

Allegedly, the studies determined that the drug was safer than an existing blood thinner, when used after total knee and hip replacement surgeries. However, the studies also allegedly “showed a greater bleeding incidence with Xarelto leading to decreased hemoglobin levels and transfusion of blood.”

She claims that the RECORD and ROCKET AF studies were flawed in nature and were conducted in a negligent manner that included a systematic misrepresentation of data and falsification of information. She claims that the FDA itself found that the studies were so flawed that their findings were unreliable, but notes that the drug received approval nonetheless.

She claims that Bayer and Johnson & Johnson intentionally misrepresented information in these studies to make the drug appear safer than it was and to gain approval of the drug, though they should have known that the drug was unsafe and could cause a gastrointestinal bleed. 

The Xarelto Gastrointestinal Bleeding Class Action Lawsuit is Case No. 2:18-cv-04682-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.