As a bellwether trial is looming in federal court in New Orleans, the makers of Xarelto are facing $2.5 billion in potential liability from patients who suffered uncontrollable internal bleeding.
Xarelto is a drug designed to thin the blood to prevent clots in patients who have an abnormal heart rhythm, who are at risk of stroke, or who have had hip or knee replacement surgery. However the drug has no antidote and the makers ignored years of danger signals.
There has been an explosion in Xarelto products liability cases against manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and Bayer, which co-markets the blood thinner.
The Xarelto docket in MDL 2592 was created in 2014 with only 21 cases, and by the end of the year, more than 400 cases were filed. By December 2015, it had exploded to 2,400 cases, six months later in April, 4,500 cases. The litigation really took off in 2016 and there are now more than 15,600 cases.
Possible $500,000 settlement value
The first bellwether (test case) trial is on April 24, 2017, and the second is set for on May 30. The two defendant companies are facing a potential liability of $2.5 billion, based on settlements in Pradaxa cases in 2014. The settlement value could be up to $500,000 in a wrongful death case, and the average settlement could be in the neighborhood of $160,000.
Xarelto was designed to replace an older drug called warfarin (Coumadin). Warfarin still in use today. It was originally approved in 1954 by the FDA, it can easily be reversed with Vitamin K, the blood element that causes clotting.
Warfarin requires the doctor who prescribed it to monitor a patient’s diet and dosage carefully. Xarelto, on the other hand, was marketed as a once-a-day dose, despite that it has a short half life: between 5-9 hours.
There was a strong profit motive to create a new drug when warfarin became generic. The lowest available price of 30 standard warfarin tablets is $4. The lowest price for 30, 5 mg Xarelto tablets? — $405.
It is clear why Xarelto became a blockbuster drug for Johnson & Johnson: In 2014, the company had sales totaling $3.7 billion for Xarelto alone.
Xarelto has no reversal agent
The FDA approved Xarelto as a once-a-day blood thinner to reduce the risk of blood clots after hip or knee replacement surgery in July 2011. A few months later in November 2011, it was approved to reduce the risk of stroke from atrial fibrillation. Then in November 2012, the agency expanded it to treat deep vein thrombosis and pulmonary embolism.
Since Xarelto went on the market, the manufacturers ignored the dangers of Xarelto. It has no reversal agent or antidote, and can cause uncontrollable internal bleeding. Also, the plaintiffs allege that Xarelto can actually cause strokes and blood clots if discontinued abruptly. The plaintiffs also charge that the makers of the drug failed to warn users and actually concealed the fact that Xarelto causes uncontrolled internal bleeding.
Meanwhile, Janssen and Bayer continue to advertise Xarelto aggressively. One TV commercial featured comedian Kevin Nealon, NASCAR driver Brian Vickers and Hall of Fame golfer Arnold Palmer. The 87-year old Palmer wore a pink sweater and said, “Treatment with Xarelto was the right move for us.” Many people are wondering if that is true in the wake of his death on September 25, 2016, which was preceded in August 2016 by surgery for gastrointestinal bleeding. See Did Xarelto, the Drug Arnold Palmer Promoted, Lead to His Death?
Xarelto Litigation Overview
The vast majority of Xarelto cases are in multidistrict litigation Eastern District of Louisiana before Judge Eldon Fallon, where the bellwether trial is coming up.
Meanwhile, a smaller cluster of 1,100 claims have been filed in the Philadelphia Court of Common Pleas in Pennsylvania state court before Judge Arnold New. Finally, there’s a small group of 31 cases in California Superior Court before Judge Kenneth Freeman in Los Angeles.
The plaintiff in the April 24 bellwether trial is Joseph Boudreaux, Jr. in Lafourche Parish, Louisiana. He was prescribed Xarelto in 2014 for atrial fibrillation. He only took the drug for 21 days before he suffered severe gastrointestinal bleeding, and he survived only because of several blood transfusions.
Companies Ignored Danger Signals About Xarelto
Evidence will be presented at the trial how Bayer and Janssen ignored many danger signals.
Studies began showing as early as 2008 that Xarelto was more dangerous than other blood-thinning drugs. The New England Journal of Medicine published articles in 2008, 2011 and 2012 all of which discussed an increased risk of adverse events.
In 2012, the FDA recorded “serious adverse events” reports about Xarelto. This was the first year after the drug was on the market and there were 2,081 serious adverse events. 151 of those were deaths, compared to only 56 deaths from warfarin.
In 2013 and 2014, the FDA required that Xarelto drugmakers include boxed warnings.
- In 2013, the FDA required that Xarelto include a warning that premature discontinuation of Xarelto® increases the risk blood clots.
- In 2014, the FDA required that Xarelto include a warning that it can cause internal bleeding. The warning must also state that a specific antidote is not available for Xarelto.
The prevailing view about a settlement is that nothing will happen until the litigation affects the stock price of Bayer and Johnson & Johnson. This may happen this year, based on settlements involving a similar blood thinner called Pradaxa.
Pradaxa was approved in 2010 before Xarelto and it was a commercial success, generating huge sales for Boehringer-Ingelheim. Unfortunately, like Xarelto, Pradaxa didn’t have an antidote for bleeding. Thousands of lawsuits were filed, and in 2014, Boehringer-Ingelheim settled 4,000 cases in state and federal courts for $650 million. Individual settlements ranged from $500,000 to $12,000.
For purposes of calculating how big a settlement for Xarelto might be, lawyers can start with the average Pradaxa settlement of $162,500. When multiplied by the 15,611 cases that are currently filed in the federal MDL, this produces a potential liability of $2.53 billion.
This is why Xarelto is an attractive addition to a personal injury practice.
How do you get more clients?
To learn about attracting potential clients for Xarelto cases, watch the webinar below sponsored by LawLytics. Do you have questions about marketing a mass torts practice? LawLytics can help. Call at 800-713-0161 or schedule our call.
At this point, it’s easy to get involved in Xarelto litigation. The court has established both short and long-form complaints. So essentially, all an attorney needs to do is find a client and fill in the blanks as appropriate.
The court has approved a plaintiff fact sheet that goes through questions about the medical history of the patient, and it’s also a fill-in-the-blanks form.
With more than 15,000 cases already, attorneys might be asking, are there any more plaintiffs out there to find? And the answer to that is yes. More than 7 million people worldwide have been prescribed Xarelto, and at least 2 million Americans have atrial fibrillation that’s treated with Xarelto. All of these people are potential plaintiffs.