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Pradaxa Lawsuit

In the fall of 2010, Pradaxa became the first anticoagulant drug the FDA approved in more than 50 years. For years, warfarin (Coumadin) had been the only available medication to reduce stroke and systemic embolism in patients with atrial fibrillation. Pradaxa’s $67 million marketing campaign promoted the fact that patients did not need frequent blood monitoring or dose adjustments, nor did they require any special dietary restrictions.

What they didn’t tell patients was that there was no antidote to reverse the anticoagulation effects of Pradaxa – and that disabling, life-threatening complications could ensue. As of November 18, 2013, there were 1,748 Pradaxa lawsuits included in the federal multidistrict litigation consolidated in the Southern District of Illinois. More than 300 lawsuits have been added to the pending dockets in just two short months as more people become aware of Pradaxa internal bleeding risks.

Boehringer Ingelheim agreed to a $650 million Pradaxa settlement in May 2014 to cover payouts to the majority of plaintiffs who had filed lawsuits in state and federal courts. The Pradaxa settlements were facilitated by U.S. District Court Judge David Herndon, who had been overseeing the consolidation of these cases on the federal level.

The Pradaxa lawsuit settlement resolves 4,000 product liability lawsuits over bleeding injuries that plaintiffs believe were directly caused by use of Boehringer’s prized anticoagulant. Despite agreeing to the settlement, Boehringer continues to deny any wrongdoing in the design, manufacture, or marketing of the drug. Each plaintiff who participates in the settlement will receive approximately $160,000.

Deaths lead to Pradaxa lawsuits

Pradaxa caused 542 deaths in 2011, despite amassing over $1 billion in sales. The drug led all other medications in the number of deaths reported that year, according to USA Today. In addition to the alarming number of deaths, there were also 2,367 cases of hemorrhaging, 644 strokes, and 291 cases of acute renal failure.

Recent studies add to the legal ammunition against Boehringer Ingelheim, the makers of Pradaxa:

  • Last year, a Cleveland Clinic study found that patients taking Pradaxa had a 33% higher risk of heart attack than patients taking warfarin.
  • Researchers from Hungary analyzed seven studies involving a total of 31,000 patients. They found that patients taking Pradaxa, Xarelto and Eliquis blood thinners experienced a three-fold risk of major bleeding events after starting the new drugs.
  • A study published in the Annals of Pharmacotherapy found that blood thinners are implicated in seven percent of hospital medication errors – sometimes with life-threatening consequences.

Pradaxa antidote shows promise in first trial

Representatives from Boehringer Ingelheim have been reportedly working on an antidote for their product, should a bleeding event occur. Scientists revealed the phase 1 results of a small clinical trial of 150 healthy volunteers at the American Heart Association’s annual scientific sessions in Dallas this month.

The new antidote showed “an immediate and complete reversal” of the drug’s anti-coagulation effect, they said, and “has a very positive safety profile.” The findings suggest that a safe and effective antidote for Pradaxa bleeding could become available in the coming years. In the meantime, patients who have been injured by the drug and their families can only seek restitution for their suffering through the court system.

Allegations against Boehringer Ingelheim

Plaintiffs who’ve filed Pradaxa lawsuits charge Boehringer Ingelheim with:

  • Negligence
  • Concealment of risk
  • Strict product liability
  • Failure to warn patients or their doctors of Pradaxa side effects
  • Failure to research drug safety and issue proper dosage recommendations, and
  • Failure to establish protocol or a remedy for adverse events involving uncontrolled bleeding

Federal Pradaxa litigation consolidated in MDL 2385

Pradaxa MDL status was granted on August 8, 2012. All federal claims were transferred to U.S. District Court Judge David Herndon in the Southern District of Illinois. There are still state cases that have not been transferred to the MDL, but streamlining the lawsuits this way eliminates duplicate discovery and maximizes judicial efficiency to speed up resolution. Consistent verdicts may prompt Boehringer Ingelheim to offer Pradaxa lawsuit settlements, rather than endure lengthy court proceedings. Four bellwether trials are scheduled to begin in August 2014.

Pradaxa plaintiffs are demanding monetary damages for:

  • Past and future medical bills
  • Lost wages and loss of future income potential
  • Emotional pain and suffering
  • Wrongful death, and
  • Punitive damages

Noteworthy Pradaxa cases

There are many different stories about the hardship that Pradaxa has caused families. Some of the notable cases include:

  • In 2011, Helen Hawkins began coughing up blood and suffering severe nosebleeds shortly after taking Pradaxa. She was hospitalized and soon died.
  • A Pradaxa patient suffered a major brain hemorrhage after spending 16 days in critical condition. His widow is seeking damages.
  • A California woman says that an aneurysm killed her husband, who took Pradaxa, within minutes.
  • Dolores Reed suffered a gastrointestinal hemorrhage four months after taking Pradaxa as prescribed by her doctor. Her daughters have filed a wrongful death suit.
  • After six months of taking the blood thinning medication, Howard Thomas Medley passed away following excessive blood loss requiring a blood transfusion. His spouse is pursuing a wrongful death suit.
  • Robert C. Tionoli experienced severe abdominal pain from a bowel obstruction that caused internal bleeding. Because he was taking Pradaxa at the time, his doctors could not stop the bleeding and he died of his injuries several months later, according to his family’s lawsuit.

Bellwether trials help gauge outcomes of Pradaxa lawsuits

Despite the similarities between the cases and the large amount of evidence compiled against Boehringer Ingelheim, it will be up to skilled and experienced Pradaxa lawyers to make the cases compelling enough to win or settle before trial.

Pharmaceutical drug injury cases tend to be more complex than others because attorneys must prove that the deaths or adverse events were directly related to the medication(s) taken – not some other underlying medical condition or lifestyle factor like obesity or a lifelong smoking habit.

The first four MDL bellwether trials scheduled for August 2014 are expected to set the tone and determine whether Pradaxa cases will move to settlement proceedings outside the courts or be remanded back to individual states to be heard before juries.

  1. Judicial Panel on Multi-District Litigations - Pending MDL Dockets
  2. USA Today – Pradaxa Target of Mass-Claims Lawsuit
  3. Med Page Today – Safety Issues Sink New Blood Thinners
  4. Medical News Today – Blood Thinners Cause 7 Percent Of All Hospital Errors
  5. Pradaxa Antidote Works Fast, Completely In Small Trial
  6. Daughters of Deceased PA Woman Sue