The multidistrict litigation pending over the blood thinning medication Xarelto has moved into pretrial proceedings in Louisiana’s Eastern District, with U.S. District Judge Eldon E. Fallon presiding.
The lawsuit, filed against Bayer and Janssen Research and Development, alleges that the drug’s manufacturers were aware of increased bleeding risks and failed to adequately warn patients who were prescribed the drug about the possible deadly side effects.
According to the reports filed in May as a part of pretrial preparations, the litigation, known as MDL 2592, now includes more than 430 lawsuits. More than 150 of were filed by family members of people who died after taking the medication.
When the Xarelto lawsuits were initially combined into multidistrict litigation on December 15, 2014, there were 33 suits included. The number could quickly eclipse 500, as more people who have suffered unexpected bleeding complication and other side effects from the medication come forward.
Xarelto is an anticoagulant that was marketed as an easier and more effective alternative to the common blood thinner warfarin, more commonly known by its brand name Coumadin. Xarelto belongs to a new generation of drugs, known as direct thrombin inhibitors.
According to these suits, Xarelto may have played a role in a variety of blood-related medical problems, several of which can lead to death or permanent disability.
These include strokes, hemoglobin decreases, adrenal bleeds, deep vein thrombosis, epidural hematoma, pulmonary embolism and hemorrhaging in the retinas, brain and gastrointestinal tract.
Most blood thinners can be linked to isolated cases of hemorrhaging, because they are designed to prevent blood from clotting.This may, by its very nature, make it difficult to control bleeding.
This means that patients on both Xarelto and warfarin are at an increased risk of uncontrolled bleeding stemming from an otherwise minor injury.
There is a difference, however. When someone who has been taking warfarin suffers a skin laceration or internal injury, an antidote can be given that immediately begins to reduce the risk of severe hemorrhaging.
Other blood thinners can be removed from the blood through dialysis or other treatments, allowing the blood to clot and stop an uncontrollable bleed.
Xarelto has no antidote; there is no way to reverse the effects of the drug once it is in a patient’s system.
We’ve previously shared details on 12 new California lawsuits against Xarelto alleging GI bleeding and stroke injuries, adding to the legal complaints being faced by the blood thinner…
Two studies — one sponsored by Bayer and the other by Janssen — support the defense’s claim that Xarelto does not induce a higher risk of bleeding than other coagulants.
Published in the New England Journal of Medicine on September 8, 2011, the first study compared the rates of bleeding in patients who took Xarelto versus those who tool warfarin.
The conclusion of this study was that there were no significant differences between the effects of the two drugs. The second study compared Xarelto to enoxaparin and found similar results.
Earlier this year, another manufacturer-sponsored drug trial began enrolling 7,000 patients nationwide.
Thus far, none of these studies have mentioned the lack of antidote as a factor in complications with the medication.
Questions About The Marketing of Xarelto
New information has surfaced that shows the drug companies may have actually been more aware of the dangers than previously believed, and that the warnings were withheld on purpose.
The first lawsuit against Xarelto, filed during the middle of the year in 2014, wasn’t the first time questions were raised about the marketing of the drug and its safety record.
In fact, the FDA sent the manufacturers a warning letter in 2013 due to problems with the print advertising for the medication.
According to the letter, the advertisements minimized the risks of the drug while putting emphasis only on the benefits.
While bleeding complications were mentioned in the ad, the letter issued by the FDA reiterated that this was the most common adverse reaction to the medication.
Many of the lawsuits allege that the makers of Xarelto not only minimized possible side effects, but that they intentionally hid the increased risk of bleeding and other downsides of the medication in their marketing campaign.
A suit filed by Mary Walker against Janssen Research and Development (case number 2:15-cv-01971) claims the company marketed Xarelto “with no regard to accuracy and repercussions of their misleading advertising in favor of increasing sales.”
According to the documents filed in conjunction with Walker’s suit, Coumadin or the generic warfarin costs only a few hundred dollars annually.
At the same time, a daily dose of Xarelto will cost patients or their insurance company about $3,000 a year. Meanwhile, warfarin has been in used as an anticoagulant since 1954, and yields the same results. This claim is, in fact, backed up by the manufacturers’ own research.
Proper Dosing and Administration
Warfarin requires regular monitoring for those who take the drug, which requires several visits to the doctor each year for blood work.
According to marketing materials for Xarelto, this new generation of blood thinners does not require such monitoring. Instead, the medication was prescribed as a one-size-fits-all treatment, where it was unnecessary to monitor a patient’s therapeutic levels.
In a study conducted by the Institute for Safe Medication Practices and cited in at least one lawsuit against Xarelto, the researchers questioned whether regular monitoring might actually reduce the risks to some patients who are taking the drug. [ISMP]
The institute found more than 350 injuries associated with Xarelto use.
This number might be reduced, they proposed, if Xarelto doses were better matched to changing blood levels throughout the day instead of taken once a day.
Xarelto, which was approved by the Food and Drug Administration for use in the United States in 2011, continues to be a mainstay in print and television advertising despite the ongoing litigation.
The fierce marketing campaign seems to be working, too. Johnson & Johnson, the parent company of Janssen Research, took in $1.5 billion from the drug last year, according to company sales figures.