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Pradaxa Lawsuit

Pradaxa Lawsuit

Pradaxa is a blood-thinning drug that had no reversal agent until years after it was approved. Thousands of lawsuits have been filed by people who were injured by uncontrollable bleeding, and a $650 million settlement was reached in 2014.

What You Can Do & How We 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.

UPDATE: $650 Million Settlement Resolves 4,000 Pradaxa Lawsuits

In May 2014, Boehringer Ingelheim announced they will pay $650 million to settle up to 4,000 lawsuits involving Pradaxa. The settlement provides an average payout of $162,500 per case.

Pradaxa Lawsuits Centralized in Multi-District Litigation (MDL)

In 2012, federal judges created a Multi-District Litigation (MDL No. 2385) in the U.S. District Court for Illinois to centralize lawsuits involving Pradaxa. under Judge David Herndon. In just two years, the size of the MDL skyrocketed from 72 lawsuits to over 2,600 lawsuits. Thousands of additional cases were centralized at the state level in “mass-torts.”

What is Pradaxa?

Pradaxa (dabigatran) is a blood-thinning medicine created by Boehringer Ingelheim. It was approved by the FDA in 2010 to prevent strokes associated with atrial fibrillation (“fluttering” heart rhythm) . Pradaxa reduces the risk of ischemic strokes by inhibiting thrombin, an enzyme that is necessary for the formation of blood clots.

In April 2014, Pradaxa was approved for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral blood-thinner for 5-10 days. In recent years, Pradaxa has been increasingly used off-label.

What is the problem?

When Pradaxa was approved, it had no efficient reversal mechanism. Only dialysis can remove Pradaxa from the bloodstream and stop its blood-thinning effects. Unfortunately, dialysis takes 2-3 hours, which could be too long in the event of a bleeding emergency. Recently, Pradaxa’s lack of reversal mechanism was blamed for the death of an elderly man who hit his head during a minor fall suffered a fatal cerebral hemorrhage.

Warfarin vs. Pradaxa

Pradaxa was developed as an alternative to warfarin, a problematic medication that is difficult to administer and is inactivated by many foods containing Vitamin K. The one advantage of warfarin is that, in an emergency, a doctor can administer a simple dose of Vitamin K, which allows blood to clot and can prevent bleeding to death.

FDA Approves Praxbind: Reversal Agent to Pradaxa

In October 2015, the FDA approved Praxbind, an intravenous (IV) antidote to Pradaxa that works by neutralizing its blood-thinning effects. Click here to read more.

Common Side Effects of Pradaxa

  • Bleeding is the most serious side effect of taking Pradaxa. The RE-LY clinical trial found that up to 16.4% of Pradaxa users may experience bleeding.
  • Gastrointestinal problems are also experienced by up to 35% of people taking Pradaxa. Problems may include indigestion, abdominal pain, ulcers of the digestive tract, black or tarry stools, gastroesophageal reflux disease, and more.

Other Side Effects

FDA: Higher Risk of GI Bleeding, Lower Risk of Stroke and Death

In January 2014, the FDA launched a study to compare the bleeding risks of Pradaxa and warfarin. In May 2014, the agency issued a Safety Communication to warn that Pradaxa was associated with a 28% higher rate of gastrointestinal bleeding than warfarin, but lower rates of stroke and death, and similar rates of heart attack. After compensating for patient risk-factors, another study published in 2014 linked Pradaxa with an 85% increased risk of gastrointestinal bleeding.

Pradaxa Not Recommended for Heart Valve Patients

Pradaxa is not recommended for mechanical heart valve patients because studies have found significantly higher rates of bleeding. In 2012, the FDA published a Safety Communication to warn about an increased risk of heart attack, stroke, blood clots, and major bleeding in heart valve patients who are given Pradaxa.

Risk-Factors for Bleeding

Doctors in New Zealand published a study which found that people who are over 80 years old, have impaired kidney function, and weigh less than 60 kg have the highest risk of severe Pradaxa bleeding.

Pradaxa & the RE-LY Clinical Trial

The RE-LY clincial trial was an 18,000-patient clinical trial that compared Pradaxa to warfarin. It was a cornerstone of Pradaxa’s approval in 2010. However, Boehringer Ingelheim admitted that 22 cases of serious bleeding were not included in the trial. The drug-maker also concealed a data analysis linking Pradaxa to more fatal bleeding events than RE-LY.

In sharp contrast to the RE-LY trial, JAMA Internal Medicine published a massive study linking Pradaxa to significantly higher rates of bleeding, including a 60% increased risk of major bleeding compared to warfarin.

Findings of the RE-LY Clinical Trial and 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.
  • 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding

Routine Blood-Testing May Improve Safety

Pradaxa was marketed as superior to warfarin because it does not require routine blood-tests to adjust dosage. However, studies suggest that Pradaxa patients could benefit from blood-testing. Boehringer Ingelheim knew that blood tests and routine monitoring could improve the safety of Pradaxa, but failed to share those findings with health officials, according to a series of reports published in the British Medical Journal. In February 2014, another study found that some patients may actually benefit from blood testing on Pradaxa.

Studies of Pradaxa Bleeding Risks

  • In November 2014,  a study has found that combining common painkillers with Pradaxa could increase the risk of bleeding and blood clots.
  • In February 2013, a QuarterWatch report linked Pradaxawitho a 5-fold increased risk of hemorrhagic death compared to Coumadin (warfarin) — 19% versus 4% — based on adverse event data submitted to the FDA MedWatch system.
  • Other studies have found evidence that higher doses of Pradaxa are associated with a higher risk of heart attacks.
  • While some say the risk of bleeding may offset health benefits for certain patients, other studies have found comparable rates of bleeding among new users of Pradaxa or warfarin

Do I have a Pradaxa Lawsuit?

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.

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