Class Actions

Pradaxa Lawsuit

The class action attorneys at The Law Offices of Peter T. Nicholl are reviewing claims on behalf of patients who were prescribed the blood thinner Pradaxa and suffered severe bleeding events, including gastrointestinal bleeds and cerebral hemorrhaging.

Thousands of patients have filed lawsuits against Pradaxa’s manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc., for the pain and suffering they endured after taking the drug.

If you or someone you love suffered a severe bleeding event after taking Pradaxa, contact The Law Offices of Peter T. Nicholl for a free, no obligation consultation. We are qualified personal injury attorneys with a history of success recovering millions in verdicts and settlements for our clients. Our attorneys will not hesitate to pursue all legal options available to help you recover the justice and compensation you deserve. We work only on a contingency fee basis, which means there are no fees or costs unless we recover for your claim.

Call 410-244-7005 to schedule a free consultation.

What is Pradaxa?

Pradaxa is an anticoagulant used to reduce the risk of stroke and blood clots in people who are diagnosed with a medical condition called atrial fibrillation, which is an irregular heart beat that causes poor blood flow. It is also prescribed to patients who suffer blood clots in the veins of their legs (deep vein thrombosis) or lungs (pulmonary embolism).

Pradaxa was approved by the U.S. Food and Drug Administration (FDA) and released in the U.S. in 2010. It was initially marketed as a safer and more convenient alternative to warfarin because Pradaxa did not require patients be monitored or follow a dietary plan. Warfarin is another anticoagulant that has been in circulation for more than 60 years and requires routine blood tests.

However, a 2015 study conduct by medical researchers at the University of Pittsburgh found that when compared to warfarin, Pradaxa patients suffered:

  • Thirty-eight percent more bleeding events
  • Fifty-eight percent more major bleeding events
  • Eighty-five percent more gastrointestinal bleeding events
  • Twenty-two percent less intracranial hemorrhaging events

Researchers used “real-world clinical practice” as opposed to carefully selecting subjects for clinical trials like Boerhinger Ingelheim during Pradaxa’s testing stage. Using records from Medicare, researchers compared data from patients who had been diagnosed with atrial fibrillation and prescribed Pradaxa or warfarin. They concluded that health care providers should only prescribe Pradaxa with caution, especially with high-risk patients.

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Pradaxa Side Effects

Blood clots are a natural mechanism of the body that help stop bleeding from an injury. By blocking a clotting enzyme called thrombin, Pradaxa reduces the body’s ability to form clots and lessens the risk of a stroke.

Because they work to prevent the body from forming blood clots, all anticoagulants pose a risk of serious and fatal internal bleeding events. However, unlike other anticoagulants, Pradaxa was released without an antidote to reverse anti-clotting and stop uncontrollable bleeding events.

As a result, just one year after its release in the U.S. market, Pradaxa became the main suspect in 542 patient deaths reported to the FDA. The drug was soon linked to more reports of injury or death than any of the more than 800 drugs regulated by the Institute for Safe Medication Practices.

Patients who experienced adverse health events after taking Pradaxa often reported suffering:

  • Intracranial hemorrhaging
  • Abdominal pain and discomfort
  • Esophagitis
  • Erosive gastritis
  • Gastric hemorrhage
  • Hemorrhagic gastritis
  • Hemorrhagic erosive
  • Gastrointestinal ulcer
  • Heart attack
  • Death

Signs of these dangerous side effects include:

  • Unusual bruising or bleeding
  • Red or black stools
  • Red or brown urine
  • Vomiting that resembles coffee ground or blood
  • Coughing up blood
  • Lethargy
  • Headaches
  • Frequent nosebleeds
  • Joint pain and swelling
  • Weakness and swelling on the hands, feet, arms, lower legs or ankles
  • Dizziness or disorientation

In 2012, the FDA began evaluating new information about the risk of serious bleeding associated with Pradaxa. In response, the FDA ordered a “black box warning” be added to all Pradaxa containers to caution patients and health care providers about risks associated with the drug.

In 2015, the FDA granted accelerated approval to a Boehringer Ingelheim-manufactured antidote to Pradaxa, called Praxbind (idarucizumab).

However, by that time the FDA’s Adverse Event Reporting System database showed 973 reports of patient death related to Pradaxa. Approximately 9,000 patients had been hospitalized for internal bleeding.

Call 410-244-7005 if you or a loved one was harmed after taking Pradaxa.

Pradaxa Lawsuits

More than 4,000 patients have filed Pradaxa lawsuits against Boehringer Ingelheim, alleging the drug caused them to suffer damaging and life-threatening side effects.

The lawsuits claim the company misled patients and doctors about Pradaxa’s risks and benefits compared to warfarin. Patients also allege Boehringer Ingelheim:

  • Falsely marketed Pradaxa as a safer and more efficient alternative to warfarin
  • Misled patients and health care providers to believe that Pradaxa did not require regular monitoring or check-ups to adjust dosage
  • Failed to adequately warn or disclose the risk of serious, excessive, uncontrollable or fatal bleeding events after taking Pradaxa
  • Neglected to adequately research Pradaxa’s safety and establish variable factors in recommending doses of Pradaxa
  • Intentionally hid the dangers and risks associated with Pradaxa
  • Failed to uphold its obligation to warn consumers about risks of taking Pradaxa

Because of thousands of Pradaxa lawsuits were filed in federal court, most were consolidated into a single multidistrict litigation (MDL) in August 2012.

In February 2014, Boehringer Ingelheim stated that it had “carefully and responsibly” researched, developed and marketed Pradaxa. However, 2014 Bloomberg reports filed in Pradaxa litigation suggested Boehringer Ingelheim withheld data from the FDA showing that the drug exhibited internal bleeding side effects that were higher than expected.

In May 2014, the drug maker announced it would pay $650 million to settle the more than 4,000 state and federal Pradaxa lawsuits filed against it. By agreeing to a settlement, Boehringer Ingelheim continued to deny it had committed any negligence or wrongdoing.

Can I File a Pradaxa Lawsuit?

If your or a loved one was prescribed Pradaxa and suffered internal bleeding after taking the drug as directed, you may be entitled to compensation through a Pradaxa lawsuit.

Our skilled class action attorneys will provide you with a free, no obligation consultation to determine if you can file a Pradaxa lawsuit. If so, our attorneys will diligently pursue the makers of Pradaxa for compensation for:

  • Past and future medical expenses
  • Lost wages
  • Loss of earning capacity
  • Pain and suffering
  • Mental anguish
  • Loss of companionship
  • Physical impairment
  • Funeral expenses

Pharmaceutical conglomerates like Boehringer Ingelheim have abundant financial and legal resources designed to protect them from lawsuits filed by patients harmed by their products.

For this reason, you will need a qualified and experienced attorney to represent you during a lawsuit, and one who has the knowledge and skills to negotiate a fair and reasonable outcome that reflects the pain and suffering you endured.

Do not hesitate to contact us to schedule a free consultation and find out if you are entitled to file a Pradaxa lawsuit against Boehringer Ingelheim.

Call 410-244-7005 to find out your legal options.

Contact an Experienced Attorney

If you believe you or someone you love suffered an uncontrollable bleeding event after being prescribed Pradaxa, immediately contact The Law Offices of Peter T. Nicholl to review your legal options.

Our attorneys will provide you with a free, no obligation consultation to help you determine if you have a case against Boehringer Ingelheim that will help you obtain justice and compensation.

At The Law Offices of Peter T. Nicholl, we believe that when a pharmaceutical company’s products put patients at risk, they should be held accountable. For this reason, we will provide our qualified legal services on a contingency fee basis, so you will have no fees or costs unless we recover compensation for your claim.

Complete a Free Case Evaluation form to get started.

Contact our personal injury lawyers for a free consultation if you have been injured by another’s negligence. You may be entitled to compensation.