As our Xarelto attorneys have discussed on other blog entries, Johnson and Johnson, Bayer, U.S., and German drugmakers involved with the production and marketing of the drug are performing new studies to increase the profit potential for their flagship anticoagulant.
According to a recent article from The Wall Street Journal, the drugmakers have developed two studies to show that Xarelto is effective in treating patients with Acute Coronary Syndrome (ACS). This is significant because the U.S. Food and Drug Administration (FDA) has rejected previous efforts to seek approval to market Xarelto to ACS patients.
The reason for the rejections was that the FDA was concerned flawed study data did not establish that the benefit of Xarelto for ACS patients outweighed the known risk of serious and potentially fatal side effects.
The drug companies have also included two other blood disorders in the study, including strokes caused by clots of unknown origins and peripheral artery disease.The danger related to Xerelto is that it has been shown to cause an increased risk of internal bleeding, including intracranial bleeding.
In any dangerous drugs lawsuit, there can be a variety of claims presented under a theory of negligence. As with any negligence action, the plaintiff must prove by a preponderance of the evidence that the defendant owed a duty of care to protect foreseeable persons from foreseeable harm. There is generally no question that a drug company owes a duty of care to protect users of their pharmaceuticals from foreseeable injury.
The second element that must be established is that the drug company breached this duty of care. A breach of this duty of care is often established by showing that the drug was defectively manufactured, that the drug company failed to warn users of known dangers, or both.
A claim for failure to adequately warn of known dangers is the term attorneys use in lawsuits when there is evidence that a drug company was aware of certain risks of side effects based upon study data or reports of adverse events and did not warn the FDA, doctors, or patients.
It is well known that new drugs can mean big money for pharmaceutical companies. Xarelto has already earned over a billion dollars for the two drug companies and an expanded market for the drug would result in even more profits.
As we have seen time and time again, large corporations, including pharmaceutical giants, have been willing to risk serious personal injury to customers and the chance of future lawsuits in order to make as much as possible in sales. The more information that comes out about the dangers of their products, the more that would likely harm sales.
If you have taken Xerelto and have experienced side effects, you should tell your doctor as soon as possible. If you have been diagnosed with internal bleeding or any related condition, you should obtain a copy of your medical records and contact an attorney who regularly handles dangerous drugs litigation.
If you are the victim of Massachusetts product liability due to taking Xarelto, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
J&J, Bayer Aim to Expand Xarelto’s Uses, August 22, 2014, Wall Street Journal
More Blog Entries:
Risk for Internal Bleeding after Taking Pradaxa, August 22, 2014, Boston Dangerous Drugs Injury Lawyer Blog