And Suffered Internal Bleeding?
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The blockbuster blood-thinning drug Pradaxa (dabigatran) has been linked to hundreds of deaths and thousands of hemorrhages since it was first introduced to the market in 2010. The FDA approved Pradaxa in 2010 to reduce the risk of stroke and blood clots in persons with atrial fibrillation—also known as AFib—that is not caused by a heart valve problem. According to the FDA, “atrial fibrillation, which affects more than 2 million Americans, involves very fast and uncoordinated contractions of the heart’s two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.” In April 2014, the FDA also approved Pradaxa for the treatment of deep venous thrombosis and pulmonary embolism.
Pradaxa—developed and manufactured by the German pharmaceutical company Boehringer Ingelheim—was the first of a new generation of oral anticoagulants sold as an alternative to generic warfarin (also sold under the brand names Coumadin and Jantoven), which had been used for decades. Pradaxa and other new anticoagulants (including Xarelto, introduced in 2011 by Johnson & Johnson and Bayer) have been marketed to patients and physicians as just as effective as warfarin at preventing heart attacks or strokes but, unlike warfarin, without the inconvenience of constant blood monitoring.
A 2011 QuarterWatch Report of the Institute for Safe Medication Practices reported that adverse events linked to Pradaxa included 542 deaths and 2367 reported hemorrhages. In contrast, warfarin was linked to 72 deaths. Unlike warfarin, Pradaxa has no antidote in the case of bleeding.
In July 2014, the British Medical Journal published an article about its investigation into Boehringer’s withholding of important analysis about the need for blood monitoring to prevent hemorrhage.
From an early stage, Boehringer planned to develop and market a drug that did not require plasma level monitoring. Internal documents show that even though there had been deaths associated with major bleeds in the clinical trial and there was no antidote—a decision had been made not to support the development of a bedside monitoring device.
Boehringer’s marketing campaign for Pradaxa was highly successful and highly profitable. In its June 2013 World Preview Report, EvaluatePharma predicted that the anticoagulant market will expand by 11.5% per year through 2018, making it the fastest-growing therapeutic area. Pradaxa made over $800 million for Boehringer in the first half of 2013 alone, an increase of close to 28%.
Tables turned a year later when on May 28, 2014, Boehringer announced a $650 million settlement on behalf of approximately 4,000 claimants in individual federal and state cases who had been injured by Pradaxa.
What Does this Mean for You?
If you have experienced a bleeding event while using the drug Pradaxa, you may be legally entitled to compensation for medical costs, loss of income, and other damages.
Want to Know if You Have a Valid Legal Claim?
G&E attorneys are investigating the safety risks of Pradaxa and monitoring all developments. If you or a loved one took Pradaxa and suffered internal bleeding or a related medical condition, please contact us by submitting the form at right, or by calling us at 844-351-2394 for a confidential evaluation of your potential claim.