Pradaxa Lawsuit

close up of a group of white tablets with an out of focus prescription bottle in the background

Thousands of plaintiffs have filed lawsuits in the state court in Connecticut against Boehringer Ingelheim Pharmaceuticals over its drug Pradaxa. The lawsuits allege that Pradaxa, a blood thinner, has caused severe internal bleeding leading to injuries or death.

Defective drug attorney Bart Bernard understands the life-changing impact of an injury or death related to internal bleeding while taking the popular medication. If you or a loved one has been injured and suspect the blood thinner may be the cause, you may be eligible to file a Pradaxa lawsuit.

What is Pradaxa?

Pradaxa is the brand name of dabigatran, a medication prescribed to prevent strokes in patients who experience a dangerous type of cardiac arrhythmia known as atrial fibrillation. It works by thinning the blood so that a blood clot does not form or travel through the body.

Pradaxa has been on the market since 2010 and quickly gained a strong following because it was marketed as being easy to use. Unlike warfarin, which had been standardly prescribed for a quarter of a century, Pradaxa does not require frequent monitoring. However, excessive bleeding due to warfarin can be halted by administering a dose of Vitamin K, while Pradaxa was released without an available reversal agent.

Primary Pradaxa side effects

The most dangerous side effect linked to Pradaxa is uncontrollable bleeding. Anyone who experiences a bleeding event that requires a transfusion or hospitalization should discuss with their doctor whether to continue taking Pradaxa.

According to the manufacturer, other common side effects include indigestion, upset stomach, stomach pain, and burning. If you experience any bothersome effects and suspect it is related to Pradaxa, discuss it with your doctor.

2014 settlements and Pradaxa lawsuit update

The recent round of lawsuits is based on claims similar to those raised by thousands of injured Pradaxa patients in the earlier litigation. In 2014, the manufacturer settled more than 4,000 federal lawsuits for $650 million. The lawsuits had been filed by people who had suffered injuries due to the lack of a Pradaxa reversal agent.

There are now more than 6,00 people who have filed more than 2,000 lawsuits, mainly in Connecticut, alleging Pradaxa bleeding injuries. In many cases, the injuries occurred after the 2014 settlement.

FDA history with Pradaxa

The U.S. Food and Drug Administration (FDA) approved Pradaxa in October 2010. The approved use was the prevention of stroke in patients with non-valvular atrial fibrillation. The FDA granted approval even though a Pradaxa antidote was not available to reverse dangerous and potentially fatal excessive bleeding.

In May 2014, the FDA released the results of a study comparing dabigatran to warfarin. Comparing results across 134,000 Medicare patients, the study determined that the overall mortality rate was lower with dabigatran but that events of gastrointestinal bleeding were more common. Two months later, in July 2014, the British Medical Journal (BMJ) featured several investigations accusing Boehringer Ingelheim of burying information indicating that patients – especially the elderly, who were not represented in studies leading to Pradaxa’s approval – need to be monitored for excessive bleeding.

In October 2015, the FDA approved an anticoagulant as an antidote for Pradaxa. Praxbind (idarucizumab) may be administered intravenously to counteract the effects of Pradaxa in cases of excessive bleeding.

Pradaxa Manufacturers

Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals Incorporated, a German company with its American headquarters based in Connecticut. In April 2017, the FDA granted tentative approval to a generic form of Pradaxa by the drugmaker Glenmark. However, the lawsuits for failure to warn about serious bleeding risks are pending against Boehringer Ingelheim.

Multidistrict Litigation

Thousands of Pradaxa cases against Boehringer Ingelheim are currently pending in state courts nationwide, but the vast majority have been filed in Connecticut. These cases are filed by individuals and proceeding separately. However, the earlier round of litigation that was settled in 2014 was consolidated in federal multidistrict litigation (MDL).

In MDL, each plaintiff retains control over his or her case, but the cases are processed collectively for pretrial purposes. This means case management rulings are binding on all of the cases, but a case settlement or verdict in one case does not necessarily affect the other plaintiffs.

As the number of Pradaxa lawsuits continues to rise, it is likely that the cases will be combined in a state court version of MDL. For those with valid claims, a Pradaxa lawyer can help determine the appropriate place to file a lawsuit.

Pradaxa Settlement Amounts

Since the $650 million settlement in 2014, there have not been notable settlements. Settlements are often driven by the outcome of litigation, and while the initial verdicts were in favor of the defendant, the most recent trials have been favorable to plaintiffs.

  • On March 23, 208, a Connecticut jury sided with Boehringer Ingelheim when it found that it was not liable for Mary Boone’s March 24, 2014, death from uncontrolled gastrointestinal bleeding. Representatives for the plaintiff have appealed the verdict.
  • On May 7, 2018, another Connecticut jury found in favor of the manufacturer in a case brought by Mary Lou Gallam over a major bleeding event in 2014.
  • On October 5, 2018, a Connecticut jury found Boehringer Ingelheim not liable for the severe internal bleeding suffered by William Bledsoe of Pensacola, Florida.
  • On October 17, 2018, a West Virginia jury found Boehringer Ingelheim liable for fraud in misrepresenting the dangers of Pradaxa. It awarded the family of Betty Knight $1.2 million, which included $1 million in punitive damages
  • On May 20, 2019, a Connecticut jury awarded Eugene Roberto $542,000 over injuries suffered due to Pradaxa bleeding

Speak with a Pradaxa lawyer

If you or a loved one were prescribed Pradaxa and suffered an uncontrolled bleeding event that you believe is related, you may be entitled to compensation. Louisiana attorney Bart Bernard has committed his career to fighting for those who have been unfairly injured. Hit Hard with Bart Bernard™ – Contact Bart Bernard Injury Lawyers today to schedule a free, no-commitment case review.

Additional Pradaxa litigation resources:

  1. Pradaxa, What is Pradaxa?,
  2. FDA, FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin,