The number of deaths and serious side effects linked to Pradaxa, a blood thinner, are growing at an alarming rate, and more lawsuits are being filed against the drug’s manufacturer, Boehringer Ingelheim.
Pradaxa has been linked to over 500 deaths in the United States alone since the drug was approved by the FDA in 2010. According to Bloomberg, as of Tuesday, December 11, more than 150 lawsuits have been filed by patients and their families as more claims of severe injury and death caused by the drug were reported.
The lawsuits accuse Boehringer Ingelheim of releasing Pradaxa too quickly even though the company knew it posed a serious and deadly risk to some patients. There is also no known antidote for the uncontrolled bleeding caused by the drug. Older blood thinners like Coumadin (Warfarin) do have an antidote.
Boehringer spent $462 million marketing Pradaxa last year, hailing it as a more convenient, effective, and safer alternative to Coumadin. Sales of the drug skyrocketed and generated more than $1 billion in sales worldwide. But patients and families are questioning the information the company promoted during their marketing campaign.
At the core of the lawsuits is the fact that the company failed to warn patients and doctors of the potential for serious and uncontrollable bleeding after taking the drug as well as the lack of an antidote when the bleeding occurred.
Harold Asher filed a lawsuit against the company after his wife, Barbara Jean, suffered from internal bleeding and died from fatal hemorrhaging after taking Pradaxa to prevent another stroke. Doctors were unable to stop the bleeding because there was no antidote.
One lawyer said, “There’s no way you can reasonably market this as a safer alternative to other blood thinners.”
Emily Baier, a US representative for Boehringer, said the company “believes the product liability lawsuits filed against the company regarding Pradaxa are without merit.”
The FDA received reports of 542 deaths and 3,871 serious side effects linked to Pradaxa in 2011. Hundreds of deaths were also reported in Europe.
All of the federal cases against Boehringer will be consolidated before US District Judge David Herndon in St. Louis, Illinois. The first case is set to to go trial in March 2014.