xareltoSearcy Denney has continued its commitment to seeking justice on behalf of victims of Xarelto (rivaroxaban) with the filing of a number of additional individual lawsuits on behalf of injured patients over the past few weeks. All of these personal injury and wrongful death cases will become part of MDL No. 2592, the national, coordinated litigation effort against the manufacturers of the popular anticoagulant drug, which is pending in federal court in New Orleans before Judge Eldon Fallon.

Summary of Xarelto Cases Filed by Searcy Denney

Below is a summary of the Xarelto cases that have been recently filed by Searcy Denney against the drug companies that developed and marketed this anticoagulant drug:

  • A 77-year old West Palm Beach, Florida man suffered life-threatening bleeding around his heart after ingesting Xarelto for only 9 days. The drug was prescribed for the prevention of deep vein thrombosis (also known as DVT). Prior to suffering the hemorrhagic pericardial effusion and cardiac tamponade, this Plaintiff was an avid cyclist and fisherman.
  • A retired lawyer from Tallahassee suffered a serious bleeding injury after ingesting Xarelto for approximately one year. The drug had been prescribed after the patient suffered 2 small strokes associated with his heart arrhythmia. The patient required multiple transfusions and extensive medical treatment. Unfortunately, he never recovered from his Xarelto-induced bleeding injury and died about 7 months later.
  • A 72-year old retired contractor from Port St. Lucie, Florida suffered gross hematuria several months after his doctor prescribed Xarelto for atrial fibrillation. His physicians discontinued the drug while they searched for a source of the blood in his urine, and, unfortunately, while he was off of anticoagulants, he suffered a stroke. One of the claims in the national Xarelto litigation is that not only does the drug causes a greater incidence of bleeding injuries, patients are often left at risk for suffering a stroke as they are receiving inadequate preventative treatment. There is a high risk of stroke associated with atrial fibrillation, and, the lawsuit contends, it is likely that this patient would have never suffered this stroke if an anticoagulant with a better safety profile than Xarelto (such as Coumadin) had been prescribed. The plaintiffs contend in the MDL that this drug should be used only as a “second-line therapy,” after a patient has shown an intolerance to Coumadin and other drugs that pose fewer risks than Xarelto.
  • A Treasure Coast resident developed an upper gastrointestinal bleed and was coughing and throwing up blood after taking Xarelto for a single day. There have been a number of other reports of patients suffering bleeding incidents with both Pradaxa and Xarelto after ingestion for extremely short periods of time. In this particular case, the patient was restarted on the drug after the first bleeding incident occurred, and he then experienced a recurrence of bleeding in his stomach. This is often referred to as a “re-challenge” and provides strong evidence of a causal connection between ingestion of a drug and a particular injury.
  • A personal injury claim was filed on behalf of a 52-year old Volusia County, Florida resident who suffered a significant GI bleed requiring hospitalization and extensive testing and treatment in Daytona Beach. This patient had previously taken Coumadin, which the lawsuits contend is a safer alternative to Xarelto, but was switched over to Xarelto following his cardiac ablation and treatment for atrial fibrillation. Many patients who are involved in the national Xarelto litigation have taken Coumadin without incident, but were switched to Xarelto due to the (mistaken) belief that the drug was safer, more effective, and/or easier to use than Coumadin, as aggressively marketed to prescribing doctors and directly to patients in TV and print advertisements featuring celebrities like Kevin Nealon (former Saturday Night Live comedian), Brian Vickers (NASCAR driver), Chris Bosch (professional basketball player with Miami Heat), and Arnold Palmer (retired professional golfer).
  • A wrongful death and survival action was filed on behalf of a retired Georgia teacher who died as a result of his ingestion of Xarelto. This patient was given samples of Xarelto by a treating doctor in the Atlanta area after having taken Coumadin for several months without incident for the prevention of DVTs. After taking Xarelto for just four days, the patient suffered a catastrophic bleed involving his stomach, nose, and mouth, which required multiple blood transfusions. Unfortunately, the Xarelto-induced bleeding injury left the patient wheelchair bound and unable to care for himself. He had to leave the home that he had shared with his 84-year old wife and live in an assisted living facility, where he died of bleeding-related complications 11 months later under the care of hospice.

 

 

  • A Palm Beach County woman employed in the financial services profession was admitted to JFK Medical Center with severe anemia, hypotension, and a gastrointestinal bleed after ingesting Xarelto samples for 14 months. She had been prescribed Xarelto following diagnosis with atrial flutter and undergoing a cardiac ablation procedure to convert her heart rhythm to a normal sinus rhythm.
  • A personal injury lawsuit was filed on behalf of a Boca Raton resident who suffered a cardiac tamponade and pericardial effusion after ingesting Xarelto for 14 months, which required an extensive hospitalization and drainage of the large amount of bloody fluid that surrounded his heart. The patient had taken Coumadin for years prior to this Xarelto-induced bleeding injury without any adverse side effects.
  • A Miami-Dade County, Florida architect died of injuries sustained after ingesting Xarelto for less than two weeks. The patient was admitted to a Miami hospital with anemia and blood loss attributed to his ingestion of the drug, which was prescribed for atrial fibrillation. Despite repeated efforts, hospital personnel were unable to stabilize the patient’s significant blood loss, which led to kidney failure, abdominal bleeding, and hemorrhagic shock. A wrongful death action has been filed on behalf of his widow and estate.
  • A personal injury claim was filed on behalf of a Miami veteran originally from Cuba and his wife for severe injuries sustained after taking Xarelto for 18 months. The patient suffered an intracranial hemorrhage, which required extensive hospitalization and inpatient and outpatient therapy and rehabilitation. The patient continues to require assistance with his activities of daily living due to the residual effects of his Xarelto-induced brain bleed. Bleeding in the brain is the second most common injury that is being asserted by the thousands of plaintiffs who are prosecuting individual lawsuits in the national, multi-district litigation. GI bleeding is the most common injury amongst the living plaintiffs and survivors of those who died due to their Xarelto-induced injuries.

Update on National Efforts

The national litigation efforts against Bayer and Janssen were established on December 12, 2014. Since then, more than 6,000 individual wrongful death and personal injury lawsuits have been filed. There are also cases pending in various state court jurisdictions, predominantly in Philadelphia (a jurisdiction where pharmaceutical cases are often coordinated in the state courts due to the large number of drug manufacturers headquartered in that state).

Throughout 2015 and early 2016, the parties have been engaged in discovery efforts, which includes the production of millions of pages of documents. A number of depositions of corporate witnesses have been completed, and dozens of additional depositions are expected to be completed through the end of 2016.

The Plaintiffs have also sought production of documents and testimony from various third parties involved in the conduct of clinical trials prior to the approval of Xarelto (also known as rivaroxaban) by the FDA in July of 2011. Xarelto was first approved for use in the prevention of deep vein thrombosis (blood clots in the leg) and pulmonary emboli (blood clots in the lungs) following hip and knee replacement surgeries. Rivaroxaban received approval for use in patients with atrial fibrillation, a heart rhythm abnormality, in November of 2011. Xarelto was the second drug in a new class of anticoagulants approved by the FDA. The first drug in the class was Pradaxa, which was approved in the fall of 2010 and the subject of thousands of lawsuits filed by injured and deceased patients shortly thereafter.

Xarelto’s Questionable Safety

There are allegations in the litigation that Bayer and Janssen failed to properly conduct the single clinical trial (referred to as the ROCKET-AF study) that provided the basis for the FDA approval of Xarelto. If these allegations are proven, the Plaintiffs will be able to show that rivaroxaban is not as safe as other anticoagulants and may not be as effective either. It is critical that doctors and their patients have accurate information about the risks versus benefits of a particular drug so that proper decisions may be made. Xarelto was heralded as a new anticoagulant that was essentially an “easy button” for patients, without the need for routine blood monitoring, dietary restrictions, or concerns about drug interactions associated with Coumadin (also known as warfarin). Plaintiffs contend in the Xarelto MDL that Coumadin is a safer alternative to Xarelto. The Xarelto lawsuits also focus on the unique potential dangers associated with Xarelto’s once a day dose (which may lead to excessive levels of the drug in some patients’ systems) as well as the lack of a reversal agent. The British Medical Journal and a consumer watchdog organization have written about concerns over the safety of Xarelto and have sought a release of confidential documents that have been produced in the litigation effort.

Earlier this year, Judge Fallon chose 40 individual cases to be prepared for the first trials against the manufacturers of Xarelto, which are scheduled in begin in New Orleans in early 2017. So far, there have been no reported settlements of Xarelto cases, and the manufacturers contend that the drug is safe and effective (and that the Plaintiffs’ allegations of misconduct in the testing of Xarelto prior to marketing are false). The FDA has allowed Xarelto to remain on the market, and the warning label has not been changed to provide enhanced warnings regarding alleged increased safety risks, the need to test patients for intolerance to Xarelto as well as renal function while on the medication, and the efficacy and risks of Xarelto relative to Coumadin and other alternative therapies.

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