Pradaxa Lawsuit: A Meticulous Consumer Guide to What You Need to Know

• Pradaxa gained momentum as the result of a “RE-LY Clinical trial” (Randomized Evaluation of Long-term anticoagulant therapy) sponsored by Boehringer Ingelheim Pharmaceuticals.
• The RE-LY trial concluded that vitamin K antagonists such as warfarin are cumbersome to use, because of their multiple interactions with food and drugs, and they require frequent laboratory monitoring. Oral Vitamin K antagonists, such as warfarin, have been used in various indications for more than 50 years.
• The RE-LY Clinical trial, sponsored by Boehringer Ingelheim Pharmaceuticals, went on to suggest that there was a need for new anticoagulant agents that are effective, safe, and convenient to use. The marketing materials suggested that Pradaxa represented a therapeutic simplification and therapeutic progress because they did not require patients to undergo periodic monitoring with blood tests.
• Boehringer Ingelheim’s marketing strategy RE-LYs very heavily relied on the findings of their clinical trial and it has paid off – Pradaxa was predicted to become one of the leading therapies in the atrial fibrillation drug market.

• But, one year after its FDA approval, Boehringer Ingelheim acknowledged 260 deaths associated with the use of Pradaxa.
• Unfortunately, there are too many instances where products prove to be more dangerous than the company-sponsored studies indicated.
• Further, history is filled with examples of companies responding improperly when negative safety information comes to light about potential blockbuster products. It is inherently difficult for companies to make the right decision when profits can be so marginalized by disclosure of safety risks.
• Unfortunately, as of November 14, 2014, 35,549 reports of a serious adverse event identified Pradaxa as the primary suspect drug causing the event.
• According to voluntary reports to the FDA from health professionals and consumers, in 2011, Pradaxa surpassed all other monitored drugs in several categories, including the overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291) and stroke (644).

In October 2015, the FDA approved an antibody, Praxbind (idarucizumab), which has been shown to reduce the anticoagulation effects of Pradaxa.

Did you suffer from the following side effects while taking Pradaxa?

• Experienced a bleeding event that required blood transfusions;
• Experienced a bleeding event that required hospitalization, serious injury, and/or death.

Please contact your doctor to consider whether Pradaxa may currently, or will, cause an issue.