Xarelto Lawsuits: Understanding the Role of the FDA

Published on July 30, 2015 by

The phrase "FDA-approved" immediately grants authority and trust to a product and its manufacturers. It is used so often in advertising that we've come to think of it as an impressive credential. But after the public outcry from "FDA-approved" Xarelto and countless other endorsed medications, many patients and doctors have been left wondering: "Can the FDA really be trusted?"

Answering this question leads to some bleak, conspiratorial, and overall unsatisfying answers. But as it turns out, the real question we should be asking is: "Just how much power does the FDA really have?"

As an entity in itself, the FDA lacks the authority to require manufacturers to test patients and actively investigate the safety of a drug. Fortunately, the medical community and the patients it serves do have the power to demand this quality and protection. Patient lawsuits reflect this authority, as do movements currently formed by physicians and scientists urging for more testing and optimized dosing.

Signs of a Pushback?

Shockingly, Xarelto manufacturers didn't exhibit the least bit of discouragement or precaution after the lawsuits that had already accumulated by September 2014. Around this time, Bayer and Johnson & Johnson announced ambitious plans to launch clinical trials of Xarelto for the treatment of three new diseases.

The manufacturers began developing a cardiovascular research program that would involve testing Xarelto's effectiveness in treating acute coronary syndrome (ACS), peripheral artery disease, and embolic stroke of undetermined source.

However, despite this bold effort to widen the market for a drug already leading in sales, they have thus far been unsuccessful. In previous years, the partners requested FDA approval to treat ACS with Xarelto three separate times. Their most recent attempt resulted in a unanimous 10-0 rejection from the FDA advisory committee, indicating that there just might be a pushback against these manufacturers as a result of documented negligence.

Still, The Wall Street Journal points out that Xarelto manufacturers already have a long list of approved indications for the drug. Not to mention, this most recent program follows 8 previous efforts that the company has undergone since March 2013. However, recent lawsuits will likely stall this process.

For more information regarding the harm of Xarelto, download a copy of our free E-book, The Xarelto Disaster: How Johnson & Johnson Failed to Warn Consumers of Deadly Internal Bleeding Risks or contact our experienced legal team to discuss your particular issue with Xarelto by calling 855-423-3666.