Pradaxa MDL Adds New Lawsuit Alleging Internal Bleeding

A new lawsuit against pharmaceutical company Boehringer Ingelheim has been added to the Pradaxa MDL in Illinois. The MDL consolidates more than 120 lawsuits filed by plaintiffs claiming that they suffered internal bleeding or other Pradaxa side effects after taking the anticoagulant drug.

The Pradaxa lawsuit was first filed on August 30, 2012 in the U.S. District Court for the Middle District of Florida. It was then transferred to the MDL in the U.S. District Court, Southern District of Illinois on September 18, 2012.

Pradaxa bleeding caused plaintiff to be hospitalized for five days

The plaintiff in the case, Robert Connelly, states that his doctor prescribed Pradaxa on May 24, 2011. At that time, there was no warning that Pradaxa could cause internal bleeding.

By September 25, 2011, the plaintiff allegedly had experienced Pradaxa gastrointestinal bleeding that was so serious that he was hospitalized for five days, during which time he was given a transfusion of five units of blood and underwent a colonoscopy and esaphagogastroduodenoscopy (EGD). Because of his injuries, he says that he has suffered severe mental and physical anguish and will require ongoing monitoring of his condition to avoid future bleeding incidents. His lawsuit brings multiple counts against Pradaxa manufacturer Boehinger Ingelheim, including negligence, failure to warn, strict liability, and breach of warranty. Connelly seeks actual, punitive, economic, and non-economic damages.

More than 500 deaths linked to Pradaxa bleeding

Initially hailed as a more convenient alternative to the blood-thinner Coumadin (warfarin), Pradaxa has come under fire in recent years because it can cause uncontrolled bleeding with no known antidote. Coumadin also can cause bleeding, but the effects of Coumadin can be reversed with Vitamin K. Pradaxa bleeding has no known antidote, so its effects are far more dangerous. In fact, as of December 2011, there had been reports of more than 500 deaths linked to Pradaxa use.

The FDA issued a public safety warning about Pradaxa side effects in December 2011, and in January 2012, the drug’s label was updated to include a warning that the drug can cause uncontrolled bleeding. But for patients who had already suffered bleeding requiring hospitalization, like Robert Connelly, and those who died from such bleeding, the warning came too late. However, the FDA warning has increased awareness of this dangerous risk, as well as spurred patients who have suffered Pradaxa bleeding to file lawsuits against Boehinger Ingelheim, leading to the formation of the MDL.