Manufacturers of the blood thinner Xarelto was cleared of liability in trials over bleeding risks. This is the third time in as many months that Bayer AG and Johnson & Johnson have dodged the proverbial bullet.
A jury of five men and four women cleared the manufacturers in the most recent trial, saying they are not liable for a Mississippi’s woman severe internal bleeding. In August 2017, when the trial began, approximately 18,850 people had sued Bayer and J&J over claims that they didn’t warn patients about the potential internal bleeding associated with the medicine.
In the meantime, a new use for the drug has the potential to extend the drug to an additional 30 million patients.
Xarelto (rivaroxaban) was first approved in 2011 by the US Food and Drug Administration. Its primary use was to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a common heart rhythm disorder. It is also given to patients to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism.
As the drug has become more widely used, families and patients are blaming it for irreversible and uncontrollable internal bleeding. The lawsuits filed against the manufacturers allege the medicine is unreasonably dangerous and warnings regarding the bleeding risks associated with it are inadequate.
In their defense, J&J and Bayer maintain the warnings are more than sufficient and any supposed defectiveness did not result in patients dying.
To date, three cases have gone to trial as bellwethers, or test trials to aid both sides to assess the strength of their cases. The outcome may affect settlement decisions as well as
So far, three cases have gone to trial as bellwethers, or test trials to help both sides assess the strength of their cases. The findings of these trials may affect settlement decisions as well as the outcome of the 18,000 plus lawsuits still pending.
Unlike Dora Mingo’s case, the first two internal bleeding cases were tried in New Orleans. Joseph Boudreaux from Louisiana filed the first case. He was prescribed the drug in 2014 to treat his heart condition, but according to his lawsuit, he took the medication and subsequently suffered gastrointestinal bleeding. He spent time in the hospital and had to receive a number of blood transfusions.
Another lawsuit was filed against the drug manufacturers by Joseph Orr. It was filed on behalf of his late wife, Sharyn, who died in May 2015.According to the lawsuit, Sharyn Orr suffered a hemorrhagic stroke or bleeding on the brain a year after being prescribed Xarelto. She was prescribed the medication to treat her atrial fibrillation. Joseph Orr blamed the death of his wife on the drug companies, claiming they hadn’t provided her doctor with sufficient information about the drug and the associated bleeding risks.
In both cases, the juries sided with Bayer and Johnson & Johnson.
30 Million People to be Prescribed the Blood Thinner
Shortly after the makers of the drug won the third trial, Reuters reported that there is a possibility of a new use for the medicine that could potentially add 30 million additional patients to the existing population of approximately 25 million with atrial fibrillation.
At the European Society of Cardiology Congress in Barcelona results from laboratory studies showed that a combination of this particular blood thinner and aspirin was 24 percent more effective at preventing heart attacks and strokes in patients with severe atherosclerosis that treatment with aspirin alone. The aspirin-Xarelto combination also reduced the potential risk of a stroke by 42 percent.