Flaws In Research Design Come To Light As Xarelto Lawsuit Filings Grow In Number

June 23, 2016 – – TheProductLawyers.com comments on a recently published article from Business Insider (BI) detailing new evidence in the case against Xarelto. The FDA approved the new-generation anticoagulant from Bayer AG and the Johnson & Johnson subsidiary company, Janssen Pharmaceuticals, in 2011. However, an increasing number of lawsuits claiming increased risk of internal bleeding associated with Xarelto has drawn scrutiny from both public and official quarters.

Initially, the drug was heralded as a major breakthrough in the treatment of patients who suffered from pulmonary embolism or deep vein thrombosis. Physicians also prescribed it to those at an increased risk of stroke or patients recovering from hip and knee surgery precisely because of its purported clot prohibiting qualities. It was preferred by many over anticoagulants with a longer history of use, primarily because it did not require the intensive monitoring, dosage alteration, and dietary restrictions associated with more established drugs.

The $1.8 billion in profits drawn by the pharmaceutical giants in 2015 is overshadowed by the large number of lawsuits filed against them. BI reports that more than 5,000 lawsuits have been brought against the companies, with allegations of serious harm. Of those, a staggering ten percent allege that use of the drug caused death. According to the article, a recently released document suggests that the manufacturers of the drug knowingly withheld key data from clinical trials, thus falsifying the findings of peer-reviewed research.

Results reported to the New England Journal of Medicine were based on a subsequently recalled blood-monitoring device, according to Katie Thomas of the New York Times. If the federal legal brief from which she gleaned this information is accurate, such a revelation calls into serious question the accuracy of the reported clinical tests conducted by the manufacturers.

As the lawsuits move forward, the findings have caused both the FDA and the European Medicine Agency to delve more deeply into the matter. Reviews of the available data are expected, as well as official consideration of whether the 2011 approval of Xarelto was premature.

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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