First Xarelto Lawsuits Expected to be Joined by Hundreds, Thousands More
It is not known how many lawsuits have been filed so far in the U.S. by patients who have used the blood thinner, Xarelto, and have experienced life-threatening internal bleeding.
The number of Xarelto suits on file across the country is apparently still low. I have identified six so far, which I have listed in another blog post: “Six Lawsuits in Four States Accuse Xarelto Manufacturer, Distributor of Failure to Warn.”
However, there is good reason to expect that hundreds, perhaps thousands of Xarelto lawsuits will be filed during 2014 and 2015, no doubt including some lawsuits from Oklahoma residents who have lost a loved one or suffered unexpected ill effects from the blood-thinning drug.
According to the online pharmaceutical industry journal, Fierce Pharma, which cited the German newspaper, Der Spiegel, the following adverse effect reports were filed in Germany during 2012 and 2013:
- 2012: 750 adverse events, including 58 deaths;
- 2013 (first eight months): 968 adverse effects, including 72 deaths.
The FDA is no doubt logging hundreds of thousands of similar adverse effect reports on Xarelto here in the U.S.
Nevertheless, in June, a German newspaper reported that fewer than 10 Xarelto lawsuits had so far been brought against Bayer, the German pharmaceutical company that manufactures the anticoagulant, and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, which distributes the drug in the U.S.
The first Xarelto lawsuit in the U.S. is apparently the suit filed in a Pennsylvania federal court in February by Virginia Stunteneck of Kentucky. More petitions have been filed since then in Philadelphia, Florida, Vermont and New York.
With possibly just a handful of Xarelto legal actions filed so far, why should hundreds or even thousands of additional lawsuits be expected?
Xarelto is quite similar to Pradaxa, an anticoagulant that went on the U.S. market after winning FDA approval in October 2010, nine months before Xarelto’s FDA approval in July 2011.
Thousands of Pradaxa lawsuits have been filed in the four years since that drug hit the market. More than 2,500 federal lawsuits have been consolidated in a Pradaxa multidistrict litigation in the Southern District of Illinois.
Xarelto is likely to follow the same path. There are a lot of similarities between the two drugs:
• Both drugs are anticoagulants prescribed to patients who have an increased risk of blood clots.
• Both drugs are marketed as desirable alternatives to warfarin (Coumadin), a blood thinner that has been on the market since 1954.
• There is no known reversal agent to stop the blood-thinning effect of either drug. If a patient experiences internal bleeding, such as gastrointestinal bleeding or a cerebral hemorrhage, doctors may not be able to stop the bleeding, and death is sometimes the result. Warfarin’s anticoagulation effect can be promptly reversed with Vitamin K.
In the third quarter 2013, the number of sold units (prescriptions filled) of Xarelto surpassed for the first time the number of sold units of Pradaxa. Xarelto sales have been increasing rapidly since then.
With all of the similarities between Pradaxa and Xarelto, and the first Xarelto lawsuits now popping up around the country, it is likely that many more Xarelto lawsuits are still to come.
In May, Boehringer Ingelheim, the German manufacturer of Pradaxa, announced that it has set aside $650 million to settle the thousands of Pradaxa lawsuits that had been filed at that time. The Pradaxa lawsuits are based first and foremost on the same accusation that is made in the recent Xarelto lawsuits: the manufacturer and distributor had a duty to warn the public about the potential danger of irreversible internal bleeding and the possibility of death due to the lack of a reversal agent.
The FDA issued a June 2013 warning to Johnson & Johnson that its Xarelto ads were “false or misleading because it minimizes the risks associated with Xarelto.”
The responsibility to warn is a particularly heavy burden in the case of these anticoagulants, because the public was not without a blood-thinning drug when Pradaxa and Xarelto were introduced. Warfarin has been used successfully for 60 years, and warfarin has a reversal agent.
More Information, Consultation
For more information about Xarelto, see our webpage: “Blood Thinner Xarelto Draws Lawsuits.”
For more information about your legal rights and about the possibility of compensation if you or a loved one has experienced harms and damages due to taking Xarelto, contact our office for a free legal consultation.
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