NEW YORK — A popular drug manufacturer was aware of problems with a blood testing device, but withheld data before the critical approval process, according to The British Medical Journal.
The BMJ published findings of its investigation of Janssen, the pharmaceutical arm of Johnson and Johnson, in late September.
According to the report, Janssen did not share data from the Food and Drug Administration about problems with the INRatio device, which was used in the Phase III trial (ROCKET AF) of the anticoagulant.
Janssen also reportedly failed to share data with the safety monitoring board of the trial.
INRatio machines are handheld devices that are used to monitor blood clotting time. Clotting time is measured in INR values, which are used to determine how long it takes someones blood to clot who is taking warfarin.
The Janssen company generated data in a safety program, called the Covance recheck program, which was set up after trial investigators became concerned.
When asked by The British Medical Journal, Bayer said it “expressly contradicts with the allegation that Bayer would have withheld safety data from drug regulators and the safety monitoring board of the ROCKET AF trial.”
Patients in the United States have filed lawsuits against Janssen and Bayer for allegedly misleading users about the safety and efficacy of rivaroxaban (Xarelto).
Xarelto was approved by the FDA in 2011 for patients who had knee or hip replacement surgery in order to reduce the formation of blood clots. Later that year, the FDA expanded approval of Xarelto for patients suffering from atrial fibrillation.
In 2012, the controversial drug was fully approved by the FDA for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
How Can I File A Xarelto Lawsuit?
Our dangerous drug attorneys can help if you or someone you care about was harmed by Xarelto. Lawsuits have been filed against Janssen and Bayer by many people whom have all used Xarelto and their families seeking compensation for injuries caused by this dangerous product.
We will get all of the medical records, investigate the claim and determine if you can file a Xarelto lawsuit against the controversial drug manufacturers. If you have a case, we will file your lawsuit and take care of everything start to finish.
Our lawyers do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it in all in writing for you. Our Xarelto lawyers will help you file your lawsuit.
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You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started. We promise you in writing:
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Can I Start A Xarelto Claim?
Our Xarelto lawyers will help you file your lawsuit. To get started, you can:
- Submit the Free Case Review Box on this page, or
- Call (866) 280-3417 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have claim, we will start immediately.
WARNING: There are strict time deadlines for filing Xarelto lawsuit claims. Call now to get your claim filed and receive a settlement.