Jurors began hearing testimony this week in the first bellwether trial involving Xarelto, a blood thinner marketed by Bayer and Johnson & Johnson. The federal lawsuits are centralized in MDL No. 2592 under United States District Judge Eldon E. Fallon in Louisiana. The MDL process uses bellwether trials to help lawyers determine how a jury might respond to evidence and gauge the settlement value of similar lawsuits.
The plaintiff, Joseph Boudreaux, Jr., used Xarelto for about a month before he developed severe gastrointestinal bleeding. Mr. Boudreaux was prescribed Xarelto to reduce the risk of stroke from atrial fibrillation. He was forced to undergo several transfusions due to the bleeding event he experienced, and was hospitalized for five days. He has since required follow-up medical care. Recently, Mr. Boudreaux told the Chicago Trubune, “I don’t want anybody else to suffer like I have from that drug.”
The Xarelto MDL
There are now over 18,000 federal Xarelto lawsuits in Louisiana. All of the lawsuits involve people who experienced severe bleeding and related complications after taking Xarelto. The Xarelto lawsuits allege that the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — failed to warn about Xarelto’s potential risks, most notably, uncontrollable bleeding. Further, plaintiffs have alleged that (i) they were unaware that Xarelto was brought to market without an effective antidote, or reversing agent, which can help stem a Xarelto bleeding issue that could lead to death, and (ii) it was irresponsible of the manufacturers to claim less monitoring of patients on Xarelto was needed when, in the absence of an antidote, more monitoring would be required, all while the manufacturers aggressively marketed Xarelto in the race to replace Coumadin (warfarin). Warfarin was approved in the 1950s and it was the standard of care for decades. Warfarin is de-activated with a dose of Vitamin K, but patients cannot eat any foods that contain Vitamin K or warfarin will not work.
The second bellwether trial will also be in the U.S. District Court for the Eastern District of Louisiana. The plaintiff, Joseph Orr, is the husband of a woman who died of a cerebral hemorrhage, or uncontrollable bleeding in the brain, after taking Xarelto for one month. Two more trials will be scheduled in June 2017:
- The third trial will be located in in the U.S. District Court for the Southern District of Mississippi and it will involve Dora Mingo, a woman who suffered gastrointestinal bleeding after taking Xarelto to prevent blood clots.
- The fourth trial will involve William Henry, a man who died of gastrointestinal bleeding after taking Xarelto for atrial fibrillation. The trial will be located in the U.S. District Court for the Northern District of Texas.
Xarelto is one of the three major direct oral anticoagulants (DOACs) poised to replace Warfarin, together with Eliquis and Pradaxa. The Food and Drug Administration (FDA) approved Xarelto for use in patients who had knee or total hip replacement surgery to reduce the risk of blood clots, and also to reduce the risk of stroke in people with atrial fibrillation. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). When first released, the manufacturers advertised Xarelto as being the “first and only once-a-day prescription blood thinner”. Approved indications have been expanded several times to include the prevention of strokes in people with atrial fibrillation, to treat and reduce the recurrence of blood clots, and to reduce the risk of stent thrombosis in patients with coronary artery disease.
The FDA started approving these blood-thinning drugs in 2010, starting with Pradaxa (dabigatran) and followed by Xarelto (rivaroxaban) in 2011. At the time, neither drug had any type of reversal agent to de-activate their blood-thinning effects in an emergency. Primary care doctors prescribed these drugs because they were easy for patients to take, but emergency room doctors struggled to stop bleeding.
Xarelto is Bayer’s top-selling product, generating $3.24 billion in sales in 2016 and $2.5 billion in 2015. It is also Johnson & Johnson’s third-largest seller, bringing in $2.29 billion in 2016.
Supplemental New Drug Application
Janssen Research & Development, LLC recently announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the prescribing information for Xarelto to add a 10 mg dose to reduce patients’ risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy. This application is based on data from the Einstein Choice study, covered in our March 21st blog post. VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs), and pulmonary embolism (PE), a clot that travels to the lung. It affects more than 900,000 Americans each year, with about one-third of these occurrences being fatal. According to the American Heart Association, VTE is the third most common vascular diagnosis behind heart attacks and strokes.
The Einstein Choice study showed that patients with venous thromboembolism (VTE) taking Xarelto (rivaroxaban) — either 10 mg or 20 mg once daily over an extended time period — had significantly fewer recurrent blood clots and similar rates of major bleeding compared to those taking 100 mg of aspirin once daily. Specifically, 10 mg of Xarelto reduced the risk of recurrent VTE by 74 percent, and 20 mg by 66 percent. The study comprised patients who previously suffered a VTE, and was designed to test Xarelto’s ability to prevent a recurrence.People who required extended anticoagulation at therapeutic doses were not included, as the objective of the study was to investigate those patients for whom the treating physician was uncertain about the need for continuing anticoagulant therapy.
Once a person experiences a VTE, they are at increased risk of a repeat occurrence. Guidelines currently recommend standard anticoagulant therapy with a DOAC for three months or longer. If the application is approved, healthcare professionals who are managing patients with VTE will be able to prescribe either Xarelto 10 mg (once daily) or the currently-approved 20 mg dose (once daily) after patients have received at least six months of standard anticoagulation therapy. Xarelto currently has six indications approved by the FDA, including the treatment of VTE and reduction of the risk of recurrent VTE.
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If you or a family member have suffered injury from taking Xarelto, Eliquis or any other prescription or over-the-counter drug or pharmaceutical, you and/or your family member may be entitled to money damages.
For more information, please contact The Ahearne Law Firm, PLLC for a free initial consultation and case evaluation. Call nationwide at (845) 763-4100.