Boehringer Ingelheim settled more than 4,000 bleeding lawsuits over its “new generation” anticoagulant Pradaxa. But compensation may still be available, and patients are starting to file suit again.
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Pradaxa, the first of several “new generation” anticoagulants approved to inhibit the formation of dangerous blood clots, has been linked to a significant risk of excessive bleeding.
Most blood thinners are associated with an increased risk of bleeding; it’s how they work. But unlike warfarin, the industry standard anticoagulant, Pradaxa was introduced to the US market without an antidote. With no way of reversing Pradaxa’s effects, even minor injuries can lead to severe “bleeds,” disability and even death.
Thousands of Pradaxa lawsuits have already been settled by the drug’s manufacturer, Boehringer Ingelheim.
Hundreds of thousands of patients are and have been taking Pradaxa even prior to the release of Praxbind, the drug’s much-needed antidote. Therefore many legal experts anticipate that many lawsuits will continue to be filed due to life-threatening or even fatal bleeding events associated with the anticoagulant.
Pradaxa inhibits the function of thrombin, an enzyme crucial to the formation of blood clots.
Most patients prescribed Pradaxa have a condition called atrial fibrillation: an abnormality in the heart’s natural pacemaker causes episodes of chaotic, unsynchronized heart beats.
During an episode of Afib, the heart’s upper chambers, or atria, begin to beat out of sync with the chambers below, or ventricles. Usually, the rhythm returns to normal shortly.
But sometimes, the atria’s chaotic beating allows blood to pool in the chambers, rather than being pumped out with every beat. Over time, this stagnant reservoir of blood can clump together, forming a blood clot.
If the clot is pumped out toward the body, it can block blood vessels, reduce blood flow to vital organs or even cause a stroke. Pradaxa was designed to prevent that.
By “knocking out” an enzyme that leads to clot formation, the drug’s active ingredient, dabigatran, stops clots before they can develop and cause complications down the road.
Clots aren’t always bad. In fact, sometimes they’re lifesavers.
A common result of external trauma is an internal injury. When blood vessels become damaged inside the body, they start to leak fluid into surrounding tissues.
But for many people, internal bleeding is manageable. Specialized cell fragments called platelets come along and, accompanied by thrombin, form a tight seal over the damaged vessel.
This seal, a blood clot, reduces the rate of bleeding and gives the vessel time to heal itself. Crisis averted.
Patients on Pradaxa, along with other new anticoagulants like Eliquis and Xarelto, are working at a disadvantage in this situation. With their body’s natural clotting ability inhibited, they have no way to stop the bleed. That can be fatal if left untreated.
Sales of Pradaxa launched in October 2010. Initially approved to reduce the risk of stroke only in patients with atrial fibrillation (Afib), the drug’s approval would eventually be extended to cover the treatment and prevention of deep vein thrombosis and pulmonary embolism, as well.
On the back of those approvals, Pradaxa prescriptions ballooned until more than 850,000 Americans were taking the drug.
But without an effective reversal agent, patients soon began suffering debilitating bleeding events. To date, over 1,000 deaths have been ascribed to bleeding events aggravated by Pradaxa.
According to QuarterWatch, a publication of the Institute for Safe Medication Practices, the drug racked up 932 severe adverse event reports in the first quarter of 2011 alone.
Analyzing data submitted to the FDA, QuarterWatch found 505 cases of hemorrhage, “more than any other monitored drug including warfarin,” a blood thinner that has been used for more than 50 years and can be effectively reversed in the case of emergency.
Gastrointestinal bleeding was particularly prevalent, with at least 293 total cases.
The independent drug safety watchdog identified 120 deaths, 40 per month, linked to Pradaxa. More than half of these deaths were explicitly caused by uncontrollable bleeding. Another 543 patients required hospitalization. Patients 80 years of age and older appeared to be most at risk.
Lawsuits came soon after. By 2014, thousands were filed, claiming Boehringer Ingelheim had concealed Pradaxa’s severe bleeding risks from patients and failed to adequately warn physicians that the drug’s effects could not be reversed.
With a preliminary “bellwether” trial close on the horizon, Boehringer agreed to settle almost 4,000 lawsuits for a total of $650 million.
But many legal experts believe the litigation is far from over.