Pradaxa and Xarelto Lawsuits: Frequently Asked Questions

Pradaxa and Xarelto are anticoagulant medications that were developed as alternatives to warfarin – also known as Coumadin – a widely prescribed oral anticoagulant developed in the 1950s. Both Pradaxa and Xarelto are frequently prescribed to treat atrial fibrillation, which is a heart condition that increases the risk of blood clots and strokes.

Pradaxa was developed by Boehringer Ingelheim and introduced in October of 2010. Xarelto was developed jointly by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary and Bayer Healthcare, and was approved by the FDA to prevent strokes in 2011.

Unfortunately, both Pradaxa and Xarelto have been linked to serious injuries and deaths since their FDA approvals. Sheff Law has assembled answers to some of the most frequently asked questions about Pradaxa, Xarelto and ongoing and settled lawsuits pertaining to their use.

Why were Pradaxa and Xarelto created?

For decades, warfarin was largely the only drug available to those who required a blood thinner to prevent a stroke. While the drug often proves effective, it poses significant inconveniences, including the need for frequent blood checks, decreased effectiveness when exposed to foods that contain Vitamin K and potential incompatibility with common over-the-counter medications.

Pradaxa and Xarelto were created in part to provide more convenient alternatives to warfarin. However, these blood thinners have proven to come with significant drawbacks of their own.

How do Pradaxa and Xarelto work?

Pradaxa, which must be taken orally twice a day, works by directly inhibiting thrombin, which is classified as clotting factor “IIa.” Xarelto, which only needs to be taken once daily, works by inhibiting a different clotting factor classified as “Xa.” These both stand in contract to warfarin, which works by inhibiting vitamin K, which is needed for the synthesis of several important clotting factors.

Pradaxa and Xarelto are mainly excreted via the kidneys, and as such are generally not recommended for use by people with kidney disease. The FDA has also reached the conclusion that people with mechanical heart valves should not use Pradaxa or Xarelto.

What risks are associated with Pradaxa or Xarelto use?

One of the main risks associated with Pradaxa or Xarelto is the lack of an antidote that can rapidly reverse their anticoagulant effects. This can make major bleeding episodes extraordinarily dangerous for people taking Pradaxa or Xarelto. In October of 2015, the FDA approved Praxbind as the first reversal agent for Pradaxa, but no such antidote for Xarelto exists.

As such, there have been thousands of serious events relating to Pradaxa and Xarelto in the past two years alone. In 2014, 3,592 serious events involving Pradaxa were reported, including 752 patient deaths. An additional, 3,331 reports associated with Xarelto bleeding problems were reported as well, with 379 involving patient deaths.

Why have Pradaxa and Xarelto been in the news?

Thousands of lawsuits have been filed against the producers of Pradaxa and Xarelto over the past several years, alleging that patients suffered from uncontrollable bleeding injuries after taking the drugs. Injuries suffered include gastrointestinal, rectal and brain bleeding. The lawsuits allege that Boehringer Ingelheim, Johnson & Johnson and Bayer improperly marketed Pradaxa and Xarelto as being safer than warfarin, that they failed to establish treatment methods for people experiencing extreme bleeding and that they failed in their duty to warn consumers about the drugs’ dangers.

Where do Pradaxa and Xarelto lawsuits stand now?

In August of 2012, federal Pradaxa lawsuits were consolidated into a multidistrict litigation (MDL) in Illinois. In May of 2014, Boehringer Ingelheim agreed to pay a $650 million settlement to all 4,000 state and federal lawsuits pertaining to Pradaxa. That settlement yielded an average of $162,500 per claimant.

Since December of 2014, Xarelto lawsuits against Bayer and Johnson & Johnson have largely been consolidated in two courts, a MDL court in Louisiana and a mass tort litigation court in Philadelphia. These two cases alone represent more than 2,000 lawsuits.

If you or a loved one took Pradaxa or Xarelto and believe you’ve suffered from uncontrollable bleeding as a result of this medication, contact Sheff Law for a free, no-obligation consultation today. We have the knowledge, experiences and resources to earn you the recovery you deserve.