Pradaxa Manufacturer Settles Cases Over Uncontrolled Bleeding

Pradaxa is a blood-thinning drug prescribed to reduce the chance of stroke, deep vein thrombosis and pulmonary embolism (internal blood clots). Despite life-threatening problems that prompted its manufacturer to pay $650 million to settle a lawsuit, the company continues to defend its questionable behavior.

About 4,000 patients were plaintiffs in the lawsuit, and will receive an average $165,000 from the settlement. According to one report, some 850,000 people have been prescribed the drug, and it has been linked to more than 1,000 deaths and far more injuries.

As reported on, Pradaxa (generic name: dabigatran) was approved by the FDA in 2010 as the first in a new class of blood thinners promoted to compete with Coumadin (warfarin), which dominated the market for decades.

It wasn’t long before problems were reported among alarming numbers of patients, and then it was discovered that manufacturer Boehringer Ingelheim had withheld negative research about the drug. (See our blog, “Manufacturer Hid Research Data About Pradaxa.”) Although older blood thinners had agents to stop uncontrolled bleeding, if necessary, there was no protection against bleeding for Pradaxa.

Boehringer Ingelheim does not admit guilt nor accept that Pradaxa is unsafe. In announcing the settlement, the company offered the standard corporate “what, me?” response: “We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit,” it said. “Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years.”

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