Bellwether Xarelto Lawsuit 2024 Update

This is an old blog post that is largely outdated.  But we have a 2024 update at the bottom of the page and a current look back on what the Xarelto lawsuits were about.

Frequent readers of this blog will be aware of the litigation against Bayer/Johnson & Johnson regarding their drug Xarelto. The cases are consolidated in federal court as Multidistrict Litigation (MDL), and the presiding judge is moving proceedings along.

• November 2017 Update: we have not lost three of these cases in a row
• January 2018 Update: we just got a huge verdict that will change the course of this litigation forever

What Were the Xarelto Lawsuits About

The lawsuits against Bayer and Janssen Pharmaceuticals regarding Xarelto focused on serious allegations that the drug caused uncontrollable and sometimes fatal bleeding in patients. Plaintiffs claimed that the companies failed to provide adequate warnings about the significant risks associated with the anticoagulant, particularly the absence of an effective antidote to reverse its effects in emergencies. They argued that this lack of information led to severe, and in some cases, fatal bleeding incidents that could have been mitigated or prevented with proper warnings.

Moreover, the plaintiffs accused Bayer and Janssen of marketing Xarelto as a superior alternative to traditional anticoagulants like warfarin, emphasizing convenience over safety by understating the need for monitoring and overestimating the drug’s safety. They contended that Xarelto was defectively designed, lacking in dose flexibility needed to safely manage different patient conditions, and that it was brought to market without sufficient clinical testing to fully understand its risks.

The lawsuits included claims of negligence, asserting that the companies were negligent in their development, testing, and marketing practices. They were accused of prioritizing profit over patient safety, which allegedly led to injuries and deaths. This litigation raised significant concerns about pharmaceutical practices, regulatory oversight, and the balance between drug innovation and patient safety. The multitude of lawsuits eventually led Bayer and Janssen to agree to a $775 million settlement to resolve around 25,000 cases, without admitting to any wrongdoing, thus highlighting the complexities and responsibilities inherent in pharmaceutical development and marketing.

Summer 2015 Update

Over the past few years, product liability suits against the makers and marketers of the drug Xarelto, Bayer/Johnson & Johnson, have been cropping up across the country. The suits are mostly filed in federal court, meaning the parties consolidated them as an MDL. Judge Eldon Fallon is the sole judge presiding over the MDL, giving him the ability to make all pretrial rulings. This is the great thing about an MDL; when many different cases are consolidated, the parties can avoid doing the same discovery over and over again, while getting consistent rulings from a single judge.

Judge Fallon has made an important ruling, proposing that fifty plaintiffs be selected for a bellwether trial “pool.” These cases will go through plaintiff-specific discovery and then a series of trials to help the parties get a feel for how their cases will play out. Judge Fallon issued a discovery and trial schedule, which called for the first trial regarding Xarelto to begin on August 1 of next year. Three more trials will (hopefully) then take place over the following September. Judge Fallon recommended that the first two trials take place in his district, the Eastern District of Louisiana. The third and fourth cases could then take place in Texas and Mississippi respectively.

Judge Fallon was even treated to a Xarelto science fair, where parties from both sides informally presented information to the court about the medical/scientific issues that will likely crop up throughout the litigation.

Why This Litigation Is Happening

Xarelto is a blood thinner that was introduced back in 2011. It was hailed as a better alternative to Coumadin, which was used to treat individuals who were at risk of blood clots from deep vein thrombosis or pulmonary embolism. Chances are you have probably seen a Xarelto commercial. Chances are you have also probably seen a commercial for a law firm advertising representation for Xarelto cases.

The drug has been a huge cash cow for Bayer/Johnson & Johnson, meaning they have gone all out to market it throughout the United States. All blood thinners indeed have a risk of bleeding injuries, but Xarelto has been linked to an alarming number of issues, including severe bleeding and a few fatalities.

The main draw of Xarelto was that users do not have to undergo blood monitoring like they would if they were on Coumadin. This is being refuted though, with various studies suggesting that Xarelto users would benefit from blood monitoring since it would allow doctors to know who is at greatest risk of bleeding. When Xarelto lawsuits started rolling in, plaintiffs claimed that Bayer/Johnson & Johnson failed to warn patients about the bleeding risks associated with the drug. This was a huge deal considering that no antidote or reversal agent can be used to stop excessive bleeding caused by Xarelto.

Other anticoagulants have also come under fire over the past few years, including Pradaxa. That drug’s manufacturer, Boehringer Ingelheim, ended up forking over $650 million to settle the claims against it. Bellwether trials tend to ramp up settlement negotiations and move MDLs along. Hopefully, the same will happen here.

Litigation Timeline

 

Patent Lost in 2024 in Britain

London’s High Court ruled that Bayer’s patent for its best-selling blood thinner, Xarelto, is invalid. This decision came after challenges from Sandoz and other rival manufacturers, questioning the inventive step in the drug’s development.

As a result, the ruling could allow generic versions of rivaroxaban, the drug’s active ingredient, to enter the market. Bayer, whose Xarelto generated nearly $4.1 billion in 2023, expressed its intent to appeal the decision and seek interim injunctive relief to prevent the launch of generic versions in various dosages.

Bayer maintains belief in the patent’s validity, citing a previous confirmation by the European Patent Office in 2021. Sandoz has not yet commented on the ruling.

Xarelto Litigation Heading South in 2024

The Xarelto lawsuit have virtually all settled or have been dismissed in 2024.  We are unaware of any law firm taking on new Xarelto cases.