Pradaxa® Cerebral Hemorrhage Lawsuit

People who take Pradaxa are more likely to suffer a fatal cerebral hemorrhage. This severe, life-threatening event occurs when there is bleeding in the brain. Because Pradaxa is an anti-clotting drug with no reversal agent, bleeding that starts in the brain may be irreversible. Even doctors may be unable to stop cerebral hemorrhage before it causes permanent disability or death. Unfortunately, many people who take Pradaxa are unaware of this serious side effect.

What You Can Do & How a Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Pradaxa Overview

Pradaxa (dabigatran) is a new type of anti-clotting medication that is used by people who suffer from atrial fibrillation who are at high risk of stroke. It was developed by the pharmaceutical company Boehringer Ingelheim and was approved by the U.S. Food and Drug Administration (FDA) in 2010.

Atrial fibrillation is a common type of irregular heartbeat, in which the upper heart chambers “flutter” ineffectively. Because they do not pump all the blood out of the chamber, blood may pool in the chamber and form a blood clot. If this blood clot is pumped to the brain, it can cause an ischemic stroke.

Millions of Americans who are at risk of strokes caused by blood clots take an anti-clotting medication. In the past, most took Coumadin (warfarin). The problem with warfarin is that it is notoriously difficult to use. It requires frequent blood tests to change dosage, interacts with foods that contain Vitamin K, and carries a risk of bleeding. Fortunately, the effects of warfarin can be reversed with a dose of Vitamin K. This is not the case with Pradaxa.

Pradaxa in an Emergency

Pradaxa was developed as a once-daily pill as an alternative to warfarin. Unlike warfarin, which can be reversed with a simple dose of Vitamin K, the only way to reverse the anti-clotting effects of Pradaxa is with dialysis.

The problem with dialysis is that many doctors do not order dialysis as a first-line treatment to stop bleeding. By the time the doctor realizes that the reason the patient cannot stop bleeding is because of Pradaxa, it may be too late to use dialysis. It normally takes two or three hours for dialysis to clear 30-60% of Pradaxa from the bloodstream.

What does this mean? When a person who is taking Pradaxa suffers an unexpected bleeding event, it may be difficult or impossible to stop the bleeding. This can be life-threatening if the person is in an accident, requires emergency surgery, or suffers a cerebral hemorrhage.

Cerebral Hemorrhage

A cerebral hemorrhage, also known as “bleeding in the brain,” is a type of stroke. It is caused when an artery bursts in the brain and bleeds into the surrounding tissues. The blood kills brain cells, causing irreparable brain damage.

When blood comes in contact with brain tissue, the tissue becomes irritated and swells (called cerebral edema). When the blood begins to pool, it forms a mass called a hematoma. The hematoma significantly increases the pressure inside the skull and prevents vital blood flow to other parts of the brain. Brain tissue deprived of normal blood flow then begins to die.

Traumatic brain injuries are one of the most common causes of a cerebral hemorrhage. In fact, head trauma from falls is the number one cause of injury deaths in elderly adults. Of all the falls that cause death, nearly half are because the person hit their head. Doctors recently warned that the number of fatal cerebral hemorrhages from falls may significantly increase as more and more elderly people use Pradaxa.

Death from Fall Linked to Pradaxa Cerebral Hemorrhage

A report published in the Journal of Neurosurgery detailed the death of an 83 year-old Pradaxa patient who died of a cerebral hemorrhage after a minor fall. When the man appeared at the hospital, he was completely alert and could answer questions. Doctors performed a CT scan, which revealed a small area of bleeding in the man’s brain. The doctors gave him normal treatment to stop the bleeding — intravenous fluids and a protein that encourages blood clots. Unfortunately, the treatment was completely ineffective. By the time the doctors realized that the man was bleeding out of control because of Pradaxa, it was too late to perform dialysis. The bleeding had filled the entire left side of the man’s brain and some of the right side. He lapsed into a coma and died soon after.

Pradaxa and the RE-LY Clinical Trial

The RE-LY clinical trial was the cornerstone study that established the safety of Pradaxa. When the FDA approved Pradaxa, they were aware that the study had identified a risk of bleeding, including severe bleeding and cerebral hemorrhages.

The RE-LY study found the following rate of bleeding:

16.4% of people taking Pradaxa experience bleeding
3.3% experience serious bleeding
1.5% experience life-threatening bleeding
0.3% experience life-threatening bleeding in the brain (cerebral hemorrhage).
17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding

Pradaxa Side Effects

Other Pradaxa side effects include:

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