Pradaxa manufacturer Boehringer Ingelheim continues to face growing legal trouble over injuries patients are allegedly suffering due to its popular anticoagulant. According to FiercePharma, the company claims to currently face over 2,000 lawsuits due to Pradaxa causing severe or fatal bleeding.
“… there have been anywhere between 15,000 and 150,000 people who have bled to death on this drug Pradaxa,” commented Pradaxa lawyer Ned McWilliams, an attorney with the Levin, Papantonio law firm who practices in the areas of personal injury and pharmaceutical litigation. “They [the FDA] broke all their own rules” by letting this drug come to the market.
Pradaxa is an anticoagulating agent for which there currently exists no antidote. Patients given the drug run the risk of bleeding to death and there is no medical remedy currently available to prevent it. The drug was approved in 2010, and has earned over $2 billion in the United States for Boehringer.
Recently unsealed court documents have exposed that internal conversations regarding Pradaxa raised concerns regarding the need to more closely monitor patients. These concerns were allayed for fear of negatively affecting the product’s marketability, both with the public and with governmental regulatory bodies.
“This publication will more harm than be useful for us, neither in the market but be especially harmful in the discussions with regulatory bodies,” one email read, according to the New York Times. “Can’t this be avoided?”
However, Boehringer has continued to advocate for the viability of its product. The company notes that the FDA has approved the drug and that its safety has been proven in clinical trials. The value of these trials has been called into question by experts, however.
Patients being given Pradaxa are in need of continued blood testing. If they fail to absorb enough of the drug into their blood, the patient could be at risk for suffering a stroke. Reciprocally, if the patient absorbs too much of the drug, they are at risk for fatal bleeding.
It was this testing that the company said it could develop “in house” but declined to do so over the interest of maintaining the products image.