Xarelto Lawsuit MDL Created in Pennsylvania

Despite the fact that some Xarelto lawsuits have been coordinated in Federal Court in New Orleans, while others have been coordinated in State Court in Philadelphia, manufacturers Bayer and Johnson & Johnson continue to push the FDA for Xarelto approvals. There are hundreds of lawsuits on file with plaintiffs claiming adverse health issues and even death as a result of taking Xarelto. In light of the fact that the number of Xarelto lawsuits continue to rise, Bayer and Johnson & Johnson's FDA request for expanded uses of Xarelto will be watched closely.

Will Bayer Receive a Fourth Rejection by the FDA for Expanded Use of Xarelto?

Earlier in 2014, Bayer and Janssen (a subsidiary of Johnson & Johnson) were denied approval to expand the use of Xarelto to include those with clogged heart stents and acute coronary syndrome. This was the third rejection from the FDA for expanded uses of Xarelto which is currently only approved to treat deep vein thrombosis or pulmonary embolism. Those who have had a hip or knee replacement can also be prescribed Xarelto to prevent blood clots.

Xarelto Lawsuits Continue to Mount

Xarelto quickly captured the lion's share of the newer drugs in the blood thinner market, due to the array of FDA-approved uses. Just last year, Xarelto sales reached $1.5 billion. Because the drug is such a money-maker for the manufacturers, they are pushing for further approved uses for the drug. The latest push for yet another FDA approval comes amid serious concerns regarding the lack of an antidote to potentially fatal bleeds, as well as ever-increasing numbers of lawsuits in state and federal courts.

Xarelto Goes Head to Head with Aspirin

A new 7,000 patient trial will pit Xarelto against the common aspirin to see which is more effective in the prevention of strokes. Despite warnings regarding the use of Xarelto, the drug has already lured over one-third of former Warfarin users and is working on the other two-thirds. Warfarin is a much older blood-thinner which has been in use since the 1950's. Warfarin works well, however patients must have regular blood testing plus Warfarin reacts with some other foods and drugs.

Xarelto requires no regular blood testing, there are no known interactions with other drugs and food, seemingly making it the clear choice. That is, if you don't consider the issue of uncontrolled bleeds. A patient taking Warfarin who is bleeding profusely can be given a shot of Vitamin K to reverse the effects of the drug. There is no such antidote for the person taking Xarelto. In the event of an uncontrolled bleed, doctors have no way to stop the bleeding, and a significant number of Xarelto users have bled out while doctors watched helplessly.

What Does the FDA Think About Xarelto?

The FDA has not been so quick to approve Bayer and Janssen's applications for expanded usage of Xarelto due to the lawsuits filed as well as the number of adverse event reports received. In addition to the last three denials for expanded uses of Xarelto, the FDA has required the manufacturers to state in the labeling that:

  • When Xarelto is prematurely discontinued, thrombotic risks increase;
  • When Xarelto is not taken with an evening meal, the patient could experience decreased efficacy and,
  • Patients who take Xarelto and receive neuraxial anesthesia or a spinal puncture could have an increased risk of epidural or spinal hematomas, resulting in long-term or permanent paralysis

Have you been harmed by Xarelto? Discuss your options with us at Golomb Legal, P.C.
when you call (215) 278-4449.