More Hurdles To Come Before Xarelto Settlement Goes Through

In March of this year, it was announced that Johnson & Johnson and Bayer would be paying $775 million to settle some 25,000 pending cases related to injuries claimed to have been caused by their blood thinner drug, Xarelto. What has not been widely reported is that there may be some hurdles to overcome before that settlement goes through and the victims receive compensation.

Xarelto Background

Xarelto is a blood thinner drug developed overseas by Bayer and marketed/distributed in the U.S. by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It was approved for use in 2011 and has been widely prescribed and used ever since.

At the time of its release, the primary blood-thinner drug being prescribed was warfarin (also sold under the brand name – Coumadin). Clinical trials showed that both drugs – warfarin and Xarelto were equally effective in use as blood thinners. One big difference however, was that Xarelto cost $6,000/year and Coumadin cost $200/year. So, the question became “why should a doctor prescribe Xarelto over Coumadin/warfarin?” (Other than the fact that the doctors and pharmacies would make 30x as much by selling Xarelto.) As could be expected, Johnson & Johnson/Bayer had an answer for that.

What they told the doctors and what they advertised to the public:

  • They said that Xarelto does not require frequent blood testing as is required by Coumadin to make sure correct levels of the drug are maintained
  • They said that Xarelto does not require the patient to maintain a strict diet as is required by Coumadin.

These were the 2 main selling points to doctors and to the public which convinced doctors to begin widely prescribing Xarelto over Coumadin/warfarin to the point that by 2018, Xarelto sales were over $2.5 billion/year.

During this same time period, as more and more adverse cases involving Xarelto were reported (mostly due to excessive bleeding in patients, using Xarelto), there were some factors regarding Xarelto which were not being widely publicized to doctors and patients:

  • Bleeding events are one of the known side effects of all blood thinner drugs. Up until 2018, and unlike the case with warfarin, there was no “antidote” drug to offset bleeding events for Xarelto patients. The result was that Xarelto bleeding events were much more difficult to control and much more devastating for patients.
  • The large number of reported bleeding events in Xarelto patients made it clear that blood testing and dosage adjustments were required – contrary to what had been advertised. In 2016, Xarelto marketing materials stopped making the claim that no blood testing was required and in 2018, the FDA ordered Johnson & Johnson to STOP making the claim that no dosage adjustments were necessary because that claim was “false and misleading”.
  • Similar to the blood testing claim, the “no dietary restrictions” claim is also false and misleading in that ingestion of certain food products, including grapefruit juice, orange juice, lime juice and lemon juice can interfere with the effectiveness of Xarelto. Johnson & Johnson ceased using that claim in marketing materials sometime in 2016.

Of course, there is no evidence that Johnson & Johnson went back and proactively notified doctors that these claims – which had been the main selling points for using $6,000/year Xarelto over $200/year Coumadin – were not truthful. Doctors who had been prescribing Xarelto had no reason to go back and revisit their decision to choose that over Coumadin, so the money continued to pour in.

The Xarelto Settlement

There are some 25,600 Xarelto cases pending in various courts around the country. Of these, six (6) have gone to trial on the allegation that Johnson & Johnson/Bayer failed to adequately warn of the dangers of the drug, particularly with regard to excessive and at times uncontrollable bleeding events that it can cause. Five of the six cases were won outright by the drug manufacturer and one case resulted in a $28 million verdict for the victim (later overturned by the trial judge). All of the cases are currently on appeal.

In the wake of this litigation, Johnson & Johnson/Bayer have offered to pay $775 million to settle all of the pending cases. (Although this seems like a large amount, it is but a drop in the bucket for Johnson & Johnson - $80 billion annual revenues, and for Bayer - $40 billion annual revenues.) This offer comes out to around $30,000 on average per person, an amount which many feel is inadequate, even in light of the results of the prior trials.

There are 2 trains of thought on the viability of the settlement. The law firms leading the litigation and which have been paramount in negotiating the settlement believe that it is in the best interests of the plaintiffs to accept the settlement. Normally however, in these types of mass tort settlements, it takes a high percentage (80%-90%) of participation by the plaintiffs in order for the settlement to go through. It has been estimated that the lead law firms control about 25% of the cases and non-lead firms control the other 75%. A number of the non-lead firms have voiced concern that the settlement is inadequate, so as of this point, there is great uncertainty as to whether the settlement will go through. If not, it’s back to the drawing board for renegotiation in hopes of a “better” deal.

Talk To Dangerous Drug Lawyer If You Have Questions

If you or a loved one have suffered injury, damage or death due to a dangerous drug, medical device or other product, you or they may be entitled to compensation for their injuries. For over 65 years, the attorneys at Lattof & Lattof, PC have been helping victims and families protect their rights and obtain fair compensation for suffering and injuries due to wrongdoing of others. We will work hard to obtain justice for you against those responsible. Contact us for a free consultation and we’ll be more than happy to discuss your case and advise you of your rights.

Mitchell Lattof Jr.
Mobile Alabama Personal Injury Lawyer