Xarelto Internal Bleeding Lawsuit Information
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Did You Suffer Severe Bleeding After Taking Xarelto?
Rivaroxaban, sold under the brand name Xarelto is a new generation blood thinner that has been associated with severe and life-threatening uncontrollable bleeding events. To make matters worse, there is no antidote for these severe bleeding events. Unlike its competitor Warfarin, which has a Vitamin K reversal agent, Xarelto has no reversal agent and may cause a list of serious adverse events and complications such as:
- Wound infections
- Pulmonary embolism
- Epidural hematomas
- Hemorrhaging in the eyes and/or brain
- Gastrointestinal hemorrhage
- Adrenal bleeding
- Deep vein thrombosis
- Hemoglobin reduction
According to the FDA’s FAERS database, more than 84,000 adverse events have been reported about Xarelto, including more than 73,000 serious cases and 11,096 deaths. But understand that as concerning as these numbers are, the FDA acknowledges that only a percentage of adverse events are reported. Some experts suggest that the actual number of Xarelto adverse events and deaths could be 100 times higher.
Severe Bleeding Dangers
If you are being treated with Xarelto, it is very important that you are aware of the symptoms of a bleeding event, which may include:
- frequent nose bleeds
- unusual bleeding of the gums
- pink, red, or brown urine
- bright red stools
- black, tarry stools
- unusually heavy menstruation
- coughing up blood
- vomit that resembles coffee grounds
- wounds or surgical sites that are painful, swollen, with drainage. Hip and knee replacement patients must be particularly aware of this complication as Xarelto users are four-times more likely to experience wound complications.
Research Associates Xarelto with Increase Bleeding Risks
Researchers published a study in the British Medical Journal that found patients taking Xarelto may have twice the risk of bleeding than patients on warfarin and they had a higher risk of gastrointestinal bleeding events also.
A study published in the journal Gastroenterology also found that Xarelto patients had a 50 percent greater risk of developing gastrointestinal bleeds than patients who were taking older, alternative blood thinners.
In 2014 Boehringer Ingelheim agreed to an approximately $650 million settlement to resolve some 4,000 federal and state lawsuits that alleged the drug Pradaxa caused uncontrolled bleeding events and wrongful death. Shockingly, research is showing that Xarelto may be even more dangerous than Pradaxa.
In 2016, the journal JAMA Internal Medicine published a study that found that patients who took Xarelto experienced significantly increased rates of intracranial hemorrhage, major non-cranial bleeding events including gastrointestinal bleeding, and had an increased risk of death when compared with those who received Pradaxa.
Tens of thousands of patients have suffered severe bleeding events and thousands have died from these bleeds and complications. Xarelto was put on the market with no known reversal agent, leaving physicians with few tools to stem the flow of blood and save the patient’s life. Thousands of complaints have been filed by the families of patients who suffered catastrophic bleeding events or fatal side effects. If you or your loved one suffered a serious bleeding event after being treated with Xarelto, you may be entitled to compensation for your injuries. Contact us today to learn more.
How Xarelto Works
Xarelto inhibits the aggregation of blood platelets and decreases the production of thrombin, the enzyme needed to form blood clots. Xarelto works quickly, and within several hours of taking the medication the ability of the blood to clot is reduced.
Xarelto is manufactured by Janssen Pharmaceuticals, a subsidiary of pharma giant Bayer. The drug was approved in 2011 as a treatment for deep vein thrombosis and pulmonary embolism, for use in surgical patients to reduce the risk of blood clots, and for patients who suffer atrial fibrillation. Despite being marketed as safer than alternative blood thinning medications, tens of thousands adverse events have been reported including thousands of deaths.
A History of FDA Warnings
Two years after approving Xarelto for the market the FDA issued a warning over misleading advertising that made inaccurate dosage claims and downplayed the dangerous risks of the drug. The government watchdog agency said Janssen promoted the efficacy of the drug while failing to bring attention to its risks. The drug maker was also required to add a Black Box warning to the label regarding the increased risk of thrombotic events if the patient stops taking the drug prematurely.
Then in 2014, five more warnings and precautions were added to the label about the risks of bleeding and that there is no antidote. Also, that year, the FDA required the drug maker to:
- Expand the drug interaction warning label
- Update the Black Box warning to say the timing between the use of the drug and undergoing spinal or epidural anesthesia is not known.
- Update the adverse event warnings to include thrombocytopenia (low platelet count) and hepatitis.
In 2016, the Warnings and Precautions label was updated to include:
- Bleeding events
- Lack of safety data regarding use by patients with renal impairment
- Drug interactions with some serotonin reuptake inhibitors
- Drug interactions with serotonin-norepinephrine reuptake inhibitors
Lawsuits Say Janssen Knew of the Bleeding Risks
More than 20,000 Xarelto lawsuits filed on behalf of patients and their families have been consolidated in multidistrict litigation in U.S. District Court for the Eastern District of Louisiana under U.S. District Court Judge Eldon E. Fallon. In addition, more than 1,700 cases have been centralized in mass tort litigation in Philadelphia.
These complaints accuse Janssen of using false clinical data to promote the medication as more effective than it is, publishing incomplete and misleading data in medical journals, including the New England Journal of Medicine. Patients also accuse the drug maker of:
- Marketing the drug as safer and more effective than alternative anticoagulants
- Continuing to market the drug as safe and effective even after research and adverse event reports show something different
- Failing to warn the medical community and their patients about the increased risk of serious and fatal bleeding events
- Failing to inform medical professionals how to stabilize and treat patients who experience these dangerous bleeding events, which leaves patients vulnerable to fatal internal bleeding.
MDL Bellwether Trials
Four cases have been selected to serve as bellwether trials for the thousands of lawsuits that have been filed and centralized for coordinated discovery and resource management. Each of the cases included in the MDL involve similar questions of fact including that the drug maker failed to warn the medical community and patients about the lack of an antidote that could reverse the effects of the drug during bleeding events and other emergency situations.
As a part of the MDL process, certain cases are selected to be heard before the court to gauge how evidence and testimony that will be repeated in thousands of cases will be received by juries. The results of the bellwether trials do not affect other cases included in the MDL, but they can have a significant effect on settlement negotiations for thousands of individual cases. MDL cases that are not settled, resolved, or dismissed from the MDL are sent back to their original court for trial. Unlike a class-action, cases in an MDL are judged on their own merits and any compensation awarded to the plaintiff is not shared with other plaintiffs.
Bellwether 1 – the case involved a patient who used Xarelto for less than 30 days when he began bleeding internally and required blood transfusions. The patient argued that the drug maker did not provide adequate warnings that would have led his physician to conduct further testing. Case No. 2:14-cv-02720.
Bellwether 2 – The second case involved a patient who died from a cerebral hemorrhage (bleeding in the brain) after using Xarelto for nearly a month. The family’s attorney argued that adequate warnings were not included on the label. Case No. 2:15-cv-03708.
Bellwether 3 – the case involved a patient who suffered serious gastrointestinal bleeding after being prescribed Xarelto as a treatment for blood clots. Case No. 2:15-cv-03469.
Bellwether 4 – the case involves a patient who died from gastrointestinal bleeding after being prescribed Xarelto for atrial fibrillation. Case No. 2:15-cv-00224. The case is scheduled for early 2018.
We Can Help
Far too many patients have experienced serious adverse events and injuries after being treated with Xarelto. Many of these patients say that if they had known of the risks of bleeding events, they would have been treated with an alternative medication. They say that by failing to warn of the increased risks of dangerous bleeds, the manufacturer denied them the opportunity to make informed healthcare decisions.
Many patients are unaware they have rights, including the right to seek compensation from drug makers for their injuries and losses. For decades, we have fought to defend those rights and we stand ready to fight for you now. If you or a family member suffered a severe bleeding event after being treated with Xarelto, contact us today. You may be eligible to seek compensation for your injuries, including significant compensation for injuries such as gastrointestinal bleeding events, stroke, infections, deep vein thrombosis, and fatal bleeding events. Contact us now to learn more about patient rights and whether you are entitled to seek compensation for your injuries.