Theodoros & Rooth PC

Manufacturer of Pradaxa Settles Lawsuits

In response to more than 4,000 legal claims concerning the side effects of the blood thinner Pradaxa, the manufacturer agreed to settle in May.

Manufactured by Boehringer Ingelheim (BI), Pradaxa is the brand name for dabigatran etexilate mesylate. Approved in 2010, Pradaxa follows in the successful footsteps of the drug Wayfarin without the dietary or testing concerns of that drug.

Blood thinners are widely used in the United States to treat and prevent blood clots and strokes. In May of this year, the U.S. Food and Drug Administration (FDA) released a study comparing the efficacy and effects of wayfarin and Praxada. Review of medical records of more than 130,000 Medicare patients, aged 65 and older, resulted in findings that include:

  • Patients who take Praxada or Wayfarin experience heart attacks, or myocardial infarction at similar rates.
  • The FDA found use of Praxada resulted in lower rates of blood-clot related deaths and stroke than Wayfarin.
  • Use of Praxada resulted in higher incidence of major gastro-intestinal bleeding than Wayfarin.

For users of Praxada, episodes of internal bleeding and other effects of the drug are associated with approximately 1,000 fatalities. Although researchers at BI are working on an antidote, there remains no remedy to bleed-outs caused by the use of Praxada. Despite this, the FDA has not recalled the drug.

Later in May, BI announced settlement of American cases against the company for injury caused by Praxada. While renewing support for the safety of the drug, the manufacturer agreed to pay $650 million to end the litigation.

Our law firm provides strong, skilled legal representation to clients in Lake and Newton County and surrounding areas in Indiana. When you have concerns about questionable medical practices or harmful drugs, seek knowledgeable legal advice.