An Alabama couple filed a lawsuit against the makers of alleging the drug caused gastrointestinal bleeding.
The plaintiffs, Kenneth and Juanita W., allege that was prescribed to Kenneth in September of 2013, however, by November of 2015 he suffered gastrointestinal bleeding as a result of taking the drug. His wife alleges loss of consortium due to the bleeding caused by .
is prescribed “for use as an oral anticoagulant, the primary purposes of which are to reduce the risk of stroke and systemic embolism in patients,” states the gastrointestinal bleeding lawsuit. It is often prescribed after hip or knee replacement surgery.
The plaintiffs allege that was introduced in July of 2011 for the prophylaxis of DVT and PE in patients undergoing hip or knee replacement surgery. But, according to the gastrointestinal bleeding lawsuit, was associated with major bleeding events in the clinical trials.
was marketed as more convenient than the safe alternative, warfarin, alleges the lawsuit. Patients using warfarin have to take blood tests and limit their diet and was supposed to be different. However, allege the plaintiffs, the drug maker’s own research showed that it was actually better for patients to undergo blood monitoring while taking .
“Defendants market and promote as a single daily dose pill that does not require the need to measure a patient’s blood plasma levels, touting it more convenient than warfarin, and does not limit a patient’s diet,” alleges the lawsuit. “The single dose and no blood testing requirements or dietary constraints are marked by Defendants as the ‘ Difference.’ However, ’s clinical studies show that is safer and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”
According to the gastrointestinal bleeding lawsuit, the drug makers based dosage and marketing on flawed studies. One doctor noted “my concern was that the dose was selected more for a marketing advantage rather than for the scientific data that was available, and was a mistake…” according to the lawsuit.
Further, the drug makers were aware that posed a greater bleeding risk, but “had ‘not chosen to utilize this information’” when it came to FDA approval, alleges the gastrointestinal bleeding lawsuit.
Approximately a year after the drug was approved, there were more than 1,000 reports of -associated serious adverse events, including 65 deaths, says the lawsuit. And the number kept growing to more than 2,000 by the end of the fiscal year, say the plaintiffs, as the drug maker continued to fail to warn the public about the dangerous side effects of the drug.
According to the gastrointestinal bleeding lawsuit, Janssen Research and Development, Johnson & Johnson, and Bayer negligently manufactured and marketed the drug.
The plaintiffs are seeking damages for personal injury, medical expenses and other economic harm, as well as loss of consortium, services, society, relationship, companionship, love and comfort..
If you suffered injuries after taking , filing a lawsuit may help you recover financial losses due to high medical bills.. The attorneys at McDonald Worley are here to help. Contact them today for a FREE case review.