A North Carolina Xarelto attorney notes that the validity of a clinical trial for the popular blood-thinning medication is drawing scrutiny. Thousands of patients are pursuing claims against the drug’s maker for severe bleeding side effects that they claim was caused by Xarelto, and affected patients may be eligible to pursue compensation by filing a North Carolina Xarelto lawsuit.
For more information, contact Attorney Group for North Carolina today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
FDA Probes Blood Monitor Device Used In Xarelto Approval Study
While a four-year drug trial involving two anti-clotting medications suggested patients taking Xarelto were less likely to experience uncontrollable bleeding than those taking warfarin, new questions about the study’s validity are casting doubt on these findings. According to the New York Times, Xarelto drug maker Johnson & Johnson and its overseas marketer, Bayer, are among those facing scrutiny by the U.S. Food and Drug Administration (FDA) for their actions and their alleged failure to disclose important information related to the study.
At the crux of the matter are indications that a blood-measurement device used in the study, the now-recalled Alere INRatio, may have given inaccurate readings. This made it difficult to determine exactly how much warfarin patients were actually administered during the study, presumably tainting its findings. This is not the first time questions about the study have been raised. Medical reviewers with the FDA expressed concerns in 2011 that patients involved in the study were not managed properly. The agency’s latest investigation into the matter is ongoing, the website reported.
How a North Carolina Xarelto Attorney Can Help
Drug manufacturers have a duty to ensure their products are accompanied by full and accurate instructions and warnings to guide prescribing doctors and other health care providers in making treatment decisions. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Patients who are injured by Xarelto may be entitled to compensation for damages, including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a patient dies from complications after taking Xarelto, family members may be entitled to compensation for the wrongful death of their loved one, including:
- Conscious pain and suffering of a loved one prior to death
- Pain, suffering, and mental anguish from the loss of a loved one
- Funeral expenses
Patients who have suffered severe side effects after taking Xarelto, as well as the families of those who have died as a result of complications with the drug, are encouraged to seek the advice of a North Carolina Xarelto attorney to learn more about their rights and remedies.
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