Approved by the Food and Drug Administration in 2010, a blood-thinner called Pradaxa was a great leap forward in the treatment of a heart disorder called atrial fibrillation. Or at least that's how it was marketed.
There was just one slight problem: Unlike the drug it was meant to replace, Pradaxa has no reversal agent, so if a person on Pradaxa has a major bleeding event, it can be extraordinarily difficult to stop the blood loss. Because many people taking Pradaxa are elderly and prone to falls, this is a serious risk -- serious enough that the FDA announced that it's conducting a postmarket evaluation of the drug.
Last November, Texas law firm Watts Guerra Craft was among the first to launch a mass-tort action against the drug's German manufacturer, Boehringer Ingelheim. Lead attorney Mikal Watts believes Boehringer "cooked" the results of the 18,000-patient clinical trial that proved the drug's safety and efficacy to the FDA. He believes the company deceived physicians, and ultimately patients, by not disclosing the lack of a reversal agent.
Boehringer denies the claims and believes in the integrity of its study. Its spokespeople say the number of deaths reported so far is not unexpected and that Pradaxa is not only much more convenient than its predecessor, warfarin, but is also more effective in reducing strokes.
This week's cover story examines one of the lawsuits, filed by the daughters of an 80-year-old woman who bled out after falling in her kitchen last December. They believe that, had their mother been taking warfarin instead of Pradaxa, she would be alive today.
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These lawsuits are in such early stages that it may be quite awhile before either side is validated. Until then, Pradaxa remains on the market, and hopefully everyone taking it has been made aware of the risks. Somehow, though, that doesn't seem likely.
Read "Pradaxa Patients Can't Stop the Bleeding," this week's cover story.