As Xarelto Lawsuit Filings Continue New Evidence Surfaces Surrounding Clinical Trials

June 23, 2016 – – TheProductLawyers.com explores evidence detailed in an article from Business Insider (BI) that bolsters claims of an exacerbated risk of bleeding associated with Xarelto. While the new-generation anticoagulant from Bayer AG and Janssen Pharmaceuticals received FDA approval in 2011, complications with its use have led to intense scrutiny from both public and private sectors.

Initially, both patients and doctors welcomed the new-generation anticoagulant. It lacked the dietary restrictions that accompanied the old guard of blood-thinning medications and required none of the meticulous dosage adjustments or constant monitoring. Physicians prescribed it to those recovering from hip or knee surgeries and individuals with an increased potential for stroke because it acted to prevent clotting in the bloodstream. This also made it ideal for patients who suffered from deep vein thrombosis or pulmonary embolism.

Since 2011, Bayer AG and Janssen Pharmaceuticals have reaped the considerable benefits of this wunderkind, drawing $1.8 billion from the U.S. market alone in 2015. However, the mounting litigation has exceeded 5,000 individual suits, according to BI. Among those lawsuits, ten percent extend the claim of harm to that of death.

According to the article, the controversy surrounding Xarelto surged dramatically following the revelation that the manufacturers potentially falsified clinical trial data. Tests were conducted using a subsequently recalled blood-monitoring device. Katie Thomas of the New York Times asserts that there’s also evidence that the pharmaceutical companies knowingly withheld crucial data from peer reviewers at the New England Journal of Medicine. This accusation is neither made nor taken lightly, and sets an ominous tone for future inquiries.

While the investigation is ongoing, revealed flaws in the clinical trials of Xarelto have brought official scrutiny to bear. Both the U.S. FDA and the European Medicine Agency are probing deeply into the data, as well as the role of the recalled blood-monitoring device in the integrity of the trials. Pending the results of their inquiries, it may also call into question the legitimacy of the 2011 FDA approval.

The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.

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