Xarelto is a new generation anticoagulant or blood thinning drug, which is formulated as a direct thrombin inhibitor (DTI) like Pradaxa, against which it was meant to compete. It is manufactured by the pharmaceutical giants Johnson & Johnson’s Janssen Pharmaceuticals and Bayer Health Care. This blood thinning prescription drug was approved by the US Food and Drug Administration (FDA) in July 2011: to avert any risk of blood clot formation in the lungs, which is a condition called pulmonary embolism; to reduce chances of deep vein thrombosis (DVT), which is blood clotting in the deep veins, usually in the legs, after a knee surgery of total hip replacement surgery; and to prevent chances of stroke and/or blood clot formation in people suffering atrial fibrillation, which is an irregularity in heartbeat.

Many individuals prescribed with Xarelto have reported experiencing one of the following side-effects of the drug shortly after using it: blood in urine; bright red or black feces; vomiting and/or coughing up of blood; frequent nosebleeds; weakness, dizziness, or headaches; swelling and/or at wound sites; brain hemorrhaging; epidural hematoma, which can permanently paralyze an individual; stroke, and so forth.

In 2012, barely a year after it was made available in the market, the FDA already received about 2081 reports of adverse events linked to Xarelto (151 of these cases were fatal). The most common, and one of the most dangerous effects commonly linked to new generation anticoagulants is excessive internal bleeding. In the case of Warfarin, the anticoagulant approved in 1954, bleeding could be reversed by the consumption of vitamin K. This is not the case for Xarelto and modern blood thinners, though, which do not have reversal agents for the bleeding they cause, making the side-effect irreversible and, so, deadly for many patients.

Xarelto lawsuits are global concerns for Johnson & Johnson and Bayer Health Care. As majority of the four million patients (in the US) have been prescribed with the drug in the past, lawsuits are only predicted to shoot up.

Excessive bleeding, brain hemorrhaging and failure to properly label the drug (to inform users of the drug’s severe effects) are the most common bases of the lawsuits facing the Xarelto’s manufacturers.


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Pharmaceutical Defects

Pharmaceutical products go through rigorous testing and research before going out in the market. Because they deal with the health of the patients, strict regulatory processes are followed in order to ensure the least amount of side effects to every patient. However, there are situations where defective or fatal products are shelved out, causing serious injuries or deaths to patients.

Because pharmaceutical drugs are also consumer products, anyone who has suffered severe side effects can go for a product liability claim against a number of people involved in the pharmaceutical drug. There are three basic types of claims for drug-related product liability. It is important to know which one applies to you and how the drug has affected your health:

  1. Pharmaceutical drugs which are defectively manufactured – this category covers any injuries which the pharmaceutical drug caused due to any defect made during the production or manufacturing of the drug, including the shipping, packaging, and even errors in labeling.
  2. Side effects caused by the pharmaceutical drugs – this category cover injuries directly caused by side effects after taking the drug. Often, drugs are out on the market for a certain time and have just recently exhibited side effects or increased risks of certain health conditions. Aside from product liability claims, punitive damages can be given if it is proven that the manufacturer was aware of the potential side effects but chose to conceal it.
  3. Inaccurate marketing of the pharmaceutical drug – whether it is the instructions, warnings, or recommendations regarding the drugs, injuries that is caused by the failure to provide necessary instructions or vital warnings regarding the dangerous effects of the drug is covered in this catergory. It also involves failing to give sufficient instructions for safe and appropriate usage can be claimed as bad advice, and anyone from the doctor, manufacturer, pharmacists or any medical provider can be taken into account.

One of the most famous product liability cases is the birth control drug Yaz. Aside from being a birth control pill, it has also been marketed as relief from severe PMS and acne, but patients have experienced severe Yaz side effects such as stroke, gall bladder disease, heart attacks, and many others. These complications are due to the drospirenone present in Yaz, which increases the likelihood of blood clots in the patient’s arms and legs. Many victims believe manufacturers of Yaz was aware of the potential side effects but hid the important data in order to sell the product.

Pharmaceutical defects can present a more complicated product liability claim compared to other products, and may require the help of a professional. In cases such as those who suffered from Yaz side effects, it would be more important to get a lawyer who specializes in drug cases.


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