More than 4,000 personal injury lawsuits have been filed over the alleged link between internal bleeding and Pradaxa.

The popular blood thinner, formally known as an anticoagulant, has been linked to life-threatening gastrointestinal, rectal and brain bleeding.

Approved by the FDA in October 2010, Boehringer Ingelheim’s Pradaxa reduces the chances of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function erratically.

Strokes are possible because clotting occurs more frequently in people who have atrial fibrillation, a condition that allows blood to pool at the bottom of the heart’s chamber. Patients with atrial fibrillation see an increased risk of stroke that is five times that of the general population. Atrial fibrillation itself is not life-threatening, but the strokes that occur as a result of the condition are more likely to be severe, with a higher incidence of death and disability.

Internal Bleeding and Pradaxa Deaths

No fewer than 260 people had fatally bled out after taking Pradaxa by November 2010. Another 540 patients using Pradaxa died in 2011.

In 2012, Boehringer Ingelheim finally warned that side effects of Pradaxa included irreversible bleeding and that there was no reversal agent available at that time.

The drug company sought FDA approval of Praxbind, the antidote/reversal agent for Pradaxa, in February 2015. Praxbind reportedly existed even before Pradaxa was approved to be sold in the United States. Why the company delayed seeking approval for Praxbind has not been explained.

Pradaxa was marketed to the health care and to consumers as a drug that was so safe, no monitoring was required.

Coumadin (warfarin) requires blood monitoring to ensure a therapeutic level is maintained. Coumadin has been used for more than 50 years, and most of the time, bleeding side effects can be brought under control by a doctor’s administration of vitamin K.

Prior to 2012, Boehringer Ingelheim did not warn that internal bleeding and Pradaxa could not be controlled by any available antidote.

Patients who have sued over internal bleeding and Pradaxa allege that monitoring patients’ doses could prove beneficial. The same dose of Pradaxa that keeps one patient from having blood clots could cause another patient to suffer internal bleeding, say some doctors.

Currently, there is not an accurate test available to monitor the level of Pradaxa in someone’s system.

Plaintiffs allege willful endangerment by Boehringer Ingelheim, because it knew or should have known that Pradaxa could cause fatal bleeding, but did not warn doctors or the public of the dangers until many people already had died.

The company released Pradaxa before the antidote Praxbind was approved, which left thousands of patients vulnerable to internal bleeding and Pradaxa side effects.

If someone you love has suffered serious bleeding side effects of Pradaxa, you could have a legal case against Boehringer Ingelheim.