Xarelto’s Quick Ascension Could Lead to a Swift Decline

Xarelto, or rivaroxban, is an anticoagulant, or blood thinner, developed by Bayer and Janssen Pharmaceuticals, Johnson & Johnson’s unit based on New Jersey, prescribed to prevent blood clot formation. Prevention of blood clot formations helps reduce any risk of strokes and heart attacks in patients who suffer from blood vessel or heart disease. Xarelto was designed to avoid the risks that results from taking other drugs such as Warfarin. Xarelto is specifically used to treat deep vein thrombosis, blood clot formation in the lungs after surgery. The drug is also prescribed to treat people with the heart rhythm disorder, atrial fibrillation to prevent strokes and embolisms. Patients who suffer from any liver or kidney problems, are pregnant or breastfeeding, are strongly advised against taking Xarelto.


Before Xarelto, patients were prescribed Warfarin, another anticoagulant, since 1954. Xarelto was first approved by the FDA in November 2011 for patients who underwent hip and knee replacement surgery. Warfarin is not the simplest drug to prescribe, like Xarelto, as the dosage varies by patient and their age, medications and diet. Patients prescribed Warfarin must have monthly blood tests to check their Vitamin K levels, as an increase of Vitamin K could have adverse effects while taking Warfarin.

Once Xarelto was approved and companies spent millions to market the drug, Xarelto quickly became one of the most popular anticoagulants, as the drug did not require constant surveillance of the patient. Even though the annual cost of Xarelto, approximately $3,000, was substantially greater than the annual cost to take Warfarin, approximately $200, patients felt Warfarin was too much of a burden to take. After a study of 14,000 patients and when contrasted with other anticoagulants such as Pradaxa and Elqiuis, Xarelto was the modern drug that closely resembled Warfarin. However, a study published by the New England Journal of Medicine revealed Warfarin was the more effective drug when compared to Xarelto.


Although Xarelto has shown positive results in some patients, such results are overshadowed by the large amount of patients with strong side effects from the drug. Based on doctors’ orders, once a patient has taken Xarelto, the patient must continue as any sudden stop will increase the likelihood of hemorrhaging, or uncontrolled bleeding, and strokes. Xarelto has led to multiple fatalities due to the inability to stop any uncontrolled bleeding. Patients who are taking Xarelto are strongly advised to notify their physician before they proceed with any epidural or spine procedures, as the risk for bleeding near the spine increases. If uncontrolled bleeding occurs around the brain, kidney, lungs or any other major organ, blood flow and functionality of the organ is disrupted. As Xarelto was designed to prevent blood clots and does not have an antidote, the uncontrolled bleeding will only stop once the drug has left the patient’s system. However, flushing out the drug through dialysis is not an option.


The first case against the drug’s developers was filed in state court in mid-2014. The plaintiff suffered extreme internal bleeding and claims Xarelto was the causing factor. The amount of lawsuits against Bayer and Johnson & Johnson have increased in the past few months. Nearly two dozen cases have been filed in federal courts. The amount of lawsuits due to the drug is expected to reach several thousand within the year. With thousands of lawsuits come large amounts of discovery to be completed by the companies. A majority of the lawsuits allege the drug does not allow the blood to clot properly, leading to uncontrollable bleeding from minor cuts. Plaintiffs allege the defendants failed to warn prescribing physicians and the patients, based on the warning label, that an antidote to stop the uncontrolled bleeding was non-existent, unlike Warfarin which has an antidote. Plaintiffs further allege the companies failed to execute a complete study, warn of the varied degrees of anticoagulation in each patient and failed to research Xarelto’s safety. Most plaintiffs believe the companies willfully endangered the patients as they withheld information in regard to the risks of life-threatening bleeding.

The Judicial Panel on Multidistrict Litigation decided to consolidate the Xarelto lawsuits for multidistrict litigation. The decision came after plaintiffs filed a motion for their lawsuits to be consolidated for pretrial proceedings. Multidistrict litigation, or MDL, is a legal procedure in federal courts created to speed up the process for complicated cases. MDL is generally requested in civil case petitions in various districts that all share similar questions of fact. Once granted, MDL is designed to help the court efficiently handle cases with large number of plaintiffs with similar issues in various federal courts. All cases are transferred from their original court to a second court known as the transferee, where discovery and other pretrial proceedings occur. If the cases do not settle or are not dismissed in the transferee court, the cases are sent back, or remanded, to their original court to prepare for trial. This year, the focus for the Xarelto MDL will be determining how to organize the lawsuits and review any of the companies’ internal documents that mention Xarelto through preliminary discovery. These initial steps are crucial as it will determine if the companies will have to pay large sums of compensation for separate cases if the cases will have to proceed to trial. The companies’ determination to settle usually depends on what a jury would most likely award in each case. Juries factor in the nature of the plaintiff’s injury, the extremity of the damage that has occurred and how much the injury has impacted the plaintiff. Other factors for the juries include the amount of pain and suffering, past and future medical expenses, lost wages and the duration the injury has occurred.

Although most corporations prefer MDL due to its efficiency, Xarelto’s developers unsuccessfully tried to fight the decision. Xarelto argued each plaintiff’s individual facts such as their medical history and alleged injuries was a greater factor than common facts, and if the lawsuits are granted MDL, an influx of copycat complaints will flood the courts. The panel granted the plaintiff’s motion for MDL as the plaintiffs all raised similar issues of fact in regard to the warning label and the severe risk of hemorrhaging, which are not negated by the individualized facts. The panel decided to consolidate all lawsuits to the Eastern District of Louisiana, describing their choice as “a geographically central forum for this nationwide litigation.”

Judge Eldon E. Fallon, the judge for the Louisiana federal court, has presided over MDL cases in the past. In 2011, Judge Fallon presided over MDL cases that involved Chinese Drywall installed in multiple properties and involved over 10,000 homeowners. The drywall was said to not only corrode the copper piping and electrical wiring in the homes, but also emit an unsettled smell which adversely affected the homeowners’ sinuses, breathing and vision. The cases settled for over $1 billion.


Pradaxa, another anticoagulant, faced similar lawsuits that were consolidated to MDL. Pradaxa was approved in October 2010 by the FDA, and like Xarelto, Pradaxa does not have an antidote for uncontrolled bleeding. Lawsuits over the drug were first petitioned in March 2012 against BoehringerIngelheim International GmbH, the developers of Pradaxa. In 2011 alone, 542 deaths due to Pradaxawere reported to the FDA. In Mid-2014, the company agreed to a $650 million settlement in hopes to resolve the 4,000 lawsuits filed. As part of their settlement statement, the company brought notice to the FDA’s positive reaffirmation of Pradaxa’s benefit-risk profile.

Despite the amount of lawsuits against Bayer and Janssen Pharmaceuticals, the number of sales for the drug has risen and is expected to continue rising. First year sales for the drug reached over $670 million in the United State and Europe. Analysts expect annual sales to reach $3.68 billion by 2018.


Recently, Bayer and Janssen Pharmceuticals announced their plans for further Xarelto approval from the FDA as the companies would like the drug to be prescribed to patients who suffer from strokes. Previously, the companies tried to receive the FDA’s approval to expand the drug’s treatment for patients with acute coronary syndrome, the blockage of blood supply to the heart. Despite its prior approval to treat atrial fibrillation, deep vein thrombosis and pulmonary embolisms, the FDA unanimously rejected the company’s request as they cited insufficient clinical data to approve the drug. The FDA’s rejection prevented the companies from reaching 1.2 million Americans who suffer from ACS.

The companies believe, as with all newly developed treatment, it is ultimately up to the doctor to understand the drug they are prescribing and to determine the best way to administer the drug, using their “common medical-sense judgment.” Despite their arguments, complaints filed still address the companies’ failure to warn of the increased risk for the severe hemorrhaging.


Generally, when injuries result from medication or a recall occurs, patients should file a lawsuit so their rights are heard. If you or a loved one has suffered any injuries from Xarelto, you may have a claim against Bayer and Janssen Pharmaceuticals. MAS Law Firm urges you to contact our office as we offer a free consultation to evaluate your case. Our experienced litigation attorneys have the knowledge, experience, and dedication to analyze the details of the injuries and complications caused by Xarelto. Contact us by calling 1-866-789-1664, emailing contact@dallasarealaw.com, or filling out the form on top of this page. Our legal team is looking forward to working on your case. 



Actos is used to treat type II diabetes. It can be used with a proper diet and exercise in order to help control blood sugar levels. It can be used with medicines such as insulin, metformin, or sulfonylurea agents. This drug pairs with the insulin in order to help the body use insulin better. Only a doctor can prescribe this medication. This medicine might come with some unwanted effects. Some effects that may occur (or may not) include:

  • Chest pain
  • Dilated neck veins
  • Extreme fatigue
  • Irregular breathing
  • Irregular heartbeat
  • Problems with teeth
  • Shortness of breath
  • Swelling of the face, finger, feet, or lower legs
  • Tightness in the chest
  • Trouble with breathing
  • Weight gain
  • Wheezing

Some of these side effects may require medical attention but not all. Your healthcare professional may be able to tell you ways in which you can reduce these side effects. Check with your doctor if these side effects continue or if you have any questions about them.

In 2011, 22,512 people reported a side effect when taking Actos. These effects include bladder cancer. Sales of this drug were suspended by medical regulators in France and Germany because of this risk. When French Medicines Agency did a study on the drug and found that people were more likely to develop a severe form of the cancer, the drug was banned. They found a 22 percent increase in bladder cancer compared to other diabetics taking another drug. The first trial of Jack Cooper vs. Takeda Pharmaceuticals for Actos Bladder Cancer Lawsuit began in February 2013.  Cooper is one of the first out of 3,000 people in the U.S to claim that the drug caused him to develop a life-threatening bladder cancer. He says he took it for two years to regulate his blood sugar levels before he was diagnosed. In the lawsuit he claims that the Japanese maker of the drug, Takeda Pharmaceuticals, concealed specific risks that should have been printed on the drug labels. Later Takeda was ordered by the FDA to include risk of bladder cancer warnings on the label. The agency by then determined that taking significant amount of doses for more than a year significantly increased the person’s risk. By that time, most European markets removed Actos.

If you or a loved one are looking for an experienced personal injury and defective drugs attorney, we are here to help you. Call us at 972.789.1664, email us at contact@dallasarealaw.com, or fill out the form on top of this page to schedule a FREE CONSULTATION to discuss your case.



Simponi, like Remicade, is a TNF blocker. It reduces the effects of a substance in the body that can cause inflammation. It is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Sometimes it is used with another drug called methotrexate.


Simponi may increase the risk of developing lymphoma, a type of cancer that affects the liver, spleen and bone marrow. It may also lower blood cells that help the body fight infections, weakening the immune system. Serious and at times fatal infections may occur, involving symptoms such as fever, chills, or sore throat.


The FDA has found that Simponi can leave the body susceptible to other diseases, as it weakens the immune system when inhibiting TNF. It has noted severe fungal development that may sometimes go undiagnosed in patients, which can lead to severe illness, and at times, death. An FDA alert noted that the drug may cause and disguise fungus infections until they have reached a point where treatment is ineffective. In 2009 a firm called Centocor joined with the FDA on a Medwatch alert about Simponi’s adverse effects.



Seroquel, or quetapine, is a drug used to treat nervous, mental, or emotional conditions such as schitzophrenia or bipolar disorder. It can be used alone or with other medicines. However, it should not be used to treat behavioral problems in older patients who suffer from Alzhemier’s disease or dementia. Extended release tablets may also be used to treat major depressive disorder in adults.


Side effects of Seroquel can include mood or behavior changes, constipation, drowsiness, headache, and trouble sleeping. Older adults with dementia may have a slightly increased chance of death. More serious side effects may include stiff muscles, high fever, tremors, or blurred vision. It may also infrequently make blood sugar level rise, causing or worsening diabetes, or significant weight gain and a rise in blood cholesterol levels.


Because dementia patients are at an increased risk of death when using Seroquel, a number of lawsuits have been filed claiming that it causes cardiovascular disease, pneumonia, and other negative side effects. In April of 2010, a lawsuit was settled by AstraZeneca for $520 million for illegally marking Seroquel for off-label uses while failing to mention its side effects. Seroquel also requires a black box warning issued by the FDA. This warning states that the drug may cause deadly strokes in the elderly, and behavioral side effects such as suicide in adolescents and young adults.



Risperdal is a medication used to treat mental/mood disorders such as schizophrenia, bipolar disorder, depression, and irritability associated with autistic disorder. It is an atypical antipsychotic; it works by helping to restore the balance of natural substances in the brain.


Risperdal is not for use in conditions involving dementia. It may cause heart failure, sudden death, or pneumonia in older adults with dementia related conditions, and may also make the patient more sensitive to temperature extremes such as very hot or cold conditions. It may also impair thinking or reactions, reducing the ability to conduct activities such as driving.


Risperdal has been linked to a number of disorders including diabetes, stroke, and neuroleptic malignant syndrome. There have been 37 reports of stroke related events, and including 16 deaths. In 2003 a warning letter was sent to physicians by Johnson and Johnson warning against the elevated risk of stroke for elderly patients. There have been charges against Johnson and Johnson citing that it illegally marketed Risperdal, and that it has encouraged physicians to dispense Risperdal for conditions other than what it is prescribed to treat. There have been felony charges made against Johnson and Johnson by the U.S. Justice department, along with a conviction that would prevent the drug being sold to health care facilities and in the Medicare program.



Revatio, a phophodiesterase-5 inhibitor manufactured by Pfizer, is commonly used to treat adults with pulmonary arterial hypertension (PAH) by relaxing blood vessels in the lungs, allowing blood to flow easily. It is also used to improve exercise ability for those with PAH. Although Revatio has not been approved for FDA use of PAH in children, has commonly been prescribed off-label to help children with high blood pressure in the vessels to improve lack of exercise ability due to PAH.


The FDA has strongly warned against the use of Revatio for PAH use in children. This is based on a clinical trial finding that assert the drug may cause increased risk of death under high doses as compared to lower doses. The trial also found that the drug does not improve a child’s exercise ability even under lower doses. Milder side effects may include headache, heartburn, diarrhea, or muscle aches.


Following the findings of the clinical trial in children, Pfizer is now required by the FDA to evaluate the risk of Revatio use in adults and its risk of death. Revatio lawsuits are currently being evaluated nationwide as a result of injuries in children stemming from the off-label use of the drug.



Remicade is a drug primarily used for reducing the signs and symptoms of Crohn’s disease in patients who have had an inadequate response to conventional therapy, and may also be used to treat plaque psoriasis. It may be used in patients six years of age and older for pediatric Crohn’s disease. Remicade is also used to treat certain types of arthritis and certain bowel diseases. Remicade works by blocking the actions of a natural substance, tumor necrosis factor alpha in the body, which helps to decrease swelling and slow or stop the damage from the disease.


Remicade may cause headache, stomach pain, or nausea. It may also rarely cause potentially fatal liver disease. Some patients have had serious infections caused by viruses, including tuberculosis or histoplasmosis, while unusual cancers have also been reported in teenagers or young children using TNF blocking drugs. The chances of getting lymphoma or other cancers are increased with the use of Remicade.


The FDA has reported 580 adverse reactions among 509,000 worldwide patients. 44 of thee reported a significant blood disorder, and at least 12 patients worldwide taking Remicade have died. Lawsuits have also been filed for tuberculosis infections. Up to 15 million Americans are estimated to have latent tuberculosis infections, which becomes active once the immune system is suppressed, as by Remicade. Lawyers are evaluating research surrounding the potential safety concerns of Remicade, involving cancer and cases of individuals who developed fungal infections.



Raptiva is a medication injected to patients with moderate to severe plaque psoriasis, and autoimmune disease that is marked by red or itchy patches on the skin. It is approved for adults who are candidates of whole body therapy or phototherapy. Raptiva works by suppressing T cells. When activated, these cells migrate to the skin and cause inflammation. Because T- cells help the body fight infection, their suppression decreases the function of the immune system and increases the body’s susceptibility to disease.


In 2009 Genetech, the manufacturer of the drug, has announced a recall on Raptiva on the basis of PML, a rare progressive disease that is caused by a virus that affects the central nervous system. Other side effects may include invasive fungal disease, viral meningitis, sepsis, or brain infection.


Potential Raptiva cases are being reviewed throughout the United States. Some Raptiva users have died as a result of PML. In 2008 the FDA issued a black boxed warning to Raptiva on the basis of a rare brain disease caused by the drug as well as other life threatening infections. Genetech has been sued in numerous states such as Michigan and California for the death of patients as a result of taking Raptiva.



Qualaquin is a drug used to treat malaria caused by mosquito bites. It works by killing malaria parasites residing in red blood cells. It is an antimalarial and may be used in combination with other drugs. The FDA has warned that it should not be used to treat leg cramps, as it may cause adverse side effects that outweigh any potential benefits gained from using the drug. It has shown to be effective in regions where resistance to chloroquine is documented. Qualaquin should not be used in the prevention of malaria.


Qualaquin may cause the following adverse reactions: prolonged QT interval, G6PD deficiency, hypersensitivity reactions, or serious cardiac arrhythemias. It may also cause severe bleeding due to a lowering of blood platelets (thrombocytopenia).  These effects may be life threating, requiring hospitalization and serious medical intervention. Use of qualaquin for leg cramps has also led to serious blood disorders.


The majority of patients who took quinine, the active drug found in Qualaquin, were using it for the treatment of leg cramps, according to an FDA study conducted from April 2005 to 2008. 24 of 38 recorded cases were of blood related illnesses, with victims hospitalized in 18 of the cases. 2 cases resulted in death of the patient. This has led qualaquin to be a controversial drug with increasing lawsuits on the rise. Hemolytic-uremic syndrome and thrombotic thrombocytopenic purpura, conditions that can cause permanent kidney damage,   led to the rise of kidney damage lawsuits.



Reglan is a prescription drug that treats short term heartburn or diabetretic gastroperesis (digestive disorder in which the stomach does not contract). It works by increasing the contractions of muscles in the upper digestive tract, which raises the rate of gastric emptying. In turn the stomach empties food to the intestines more quickly, and patients are given relief from heartburn. It is only used for short term heartburn and should never be taken for longer than twelve weeks.


Reglan has been linked to tardive dyskinesia (involuntary movements of the extremities.) It may also cause a serious movement disorder that includes uncontrollable movements of the eyes, lips, tongue, face, arms, or legs. These effects may cause users physical harm or unwanted circumstances in social settings. Research suggests this may be caused by metoclopramide, a substance found in Reglan. The risk of adverse effects is greater in older adults, women, and diabetics. Risk is also increased as length of usage increases.


Many victims have filed personal injury claims against the manufacturer of the drug. Reglan was issued a “black box” warning in 2009, an FDA mandate that requires Reglan’s manufacturer to highlight the risk of tardive dyskinesia in a boxed warning on the drug’s label. There are currently a number of lawsuits regarding the use of Reglan, claiming that the drug causes serious and irreversible side effects. There are lawsuits on the rise in both California and Pennsylvania. In November of 2012 a new lawsuit rose in San Francisco, where plaintiffs Wilma and Gordon Hellwig sought for relief via a short form complaint that joined various complaints already pending in court. Most victims of Reglan side effects are seeking compensation based on claims of tardive dyskinesia, while others claim the drug causes side effects such as cervical dystonia, blepharospasm, or neuroleptic malignant syndrome. Each of these involves involuntary movements experienced by the sufferer.