Five years after the $650 Million Pradaxa settlement, another drug company has agreed to pay big money to resolve claims that its blood thinner was a defective pharmaceutical product.
The 775 million dollar settlement covers roughly 25,000 individual lawsuits in both federal and state courts., however, this is not a class action settlement. These cases were never consolidated into any type of Xarelto class action, but instead, they were all filed individually against the manufacturers. The plaintiffs in these suits allege that Xarelto’s manufacturers knowingly sold a dangerous drug that could cause serious injury. Personal injury attorneys also argue that the manufacturers failed to warn patients about a known risk. Johnson & Johnson, which made almost $3 billion from Xarelto sales, denied liability and continued to insist the drug was safe.
In 2014, German manufacturer Ingelheim agreed to pay $650 million to settle 4,000 lawsuits concerning Pradaxa, which is a similar anticoagulant.
The Xarelto (Rivaroxaban) Story
Xarelto was approved by the FDA in July of 2011. Informally, both Xarelto and Pradaxa are in the too-much-of-a-good-thing category. These anticoagulant medications, especially Xarelto, made millions for Bayer and Johnson & Johnson, the two pharmaceutical giants which developed and sold the drug. Post-surgical patients often take anticoagulants to prevent blood clots. Such clots normally form near the surgical area. If they migrate to the heart, they can be fatal.
For years, Warfarin (Jantoven or Coumadin) was the go-to anticoagulant. It was effective but did not completely prevent clots. Additionally, doctors had to closely watch dosage, and patients had to observe strict diets. So, daily blood tests were the norm. Xarelto was a stronger drug that did not require constant monitoring.
However, unlike Warfarin, Rivaroxaban did not have an antidote. If a patient was to suddenly bleed uncontrollably, there was no way to stop it. Drugmakers knew about this fatal flaw but marketed Xarelto as a Warfarin alternative without adequate warning.
On May 7, 2018, almost seven years after Xarelto was approved by the FDA, the FDA approved Portola Pharmaceutical’s Andexxa as an antidote to reverse the effects of Rivaroxaban when bleeding needs to be stopped.
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