Orthopaedic Alerts - Implant Recall

The number of deaths and serious side effects linked to the blood thinner Pradaxa is climbing at an alarming rate, triggering a barrage of lawsuits against the drug’s manufacturer, Boehringer Ingelheim. Pradaxa has been linked to more than 500 deaths in the United States alone since the Food and Drug Administration (FDA) approved it in 2010. Bloomberg reported that as of Dec. 11, 2012, more than 150 lawsuits have been filed by patients and their families after severe injury and even death occurred after taking Pradaxa.

The lawsuits accuse Boehringer of releasing Pradaxa even when the company knew that it posed a deadly risk to some patients. Also compounding the problem is that there is no known antidote for the uncontrolled bleeding caused by Pradaxa, unlike older blood thinners like Coumadin – ­the brand name for warfarin.

Attorneys estimate that the number of federal lawsuits against Boehringer may top 4,000.

Patients, Families Say They Were Not Warned

In 2011, $462 million was spent in aggressive marketing campaigns for Pradaxa. The company marketed the drug as a more convenient, effective and safe alternative to Coumadin. As a result, the drug’s sales skyrocketed and generated more than $1 billion in sales worldwide. However, now many patients and their families are questioning the information the company promoted as the reports of adverse events pile up.

At the heart of the lawsuits against Boehringer is the company’s apparent failure to warn patients and doctors of the potential for serious, uncontrollable bleeding events from taking Pradaxa – and the lack of an antidote. One of these suits was filed by Harold Asher, whose wife, Barbara Jean, was prescribed Pradaxa to prevent her from having another stroke. However, in June 2011, she suffered internal bleeding and was rushed to the hospital, where she died from the fatal hemorrhaging.

Because there was no antidote, doctors couldn’t stop the bleeding. Bloomberg quoted one lawyer as saying: “There’s no way you can reasonably market this as a safer alternative to other blood thinners.”

Boehringer disagreed. Emily Baier, a U.S. representative for the manufacturer, told Bloomberg that the drugmaker “believes the product liability lawsuits filed against the company regarding Pradaxa are without merit.” She also said that Boehringer acted “appropriately and responsibly” in the way it developed and marketed the blood thinner.

FDA Tallies Adverse Events

Despite Beohringer’s continued claims of Pradaxa’s safety, the FDA continues to receive an alarming number of adverse event reports related to the drug. In fact, Pradaxa generated more reports of death or injury than 800 other medications, according to the Institute of Safe Medication Practices. The FDA received reports of 542 deaths and 3,871 serious side effects in 2011 alone. Hundreds of deaths were also reported in Europe.

Before the trials begin for Pradaxa lawsuits, attorneys expect the number of cases to increase. In the meantime, all of the federal cases against Boehringer were consolidated before U.S. District Judge David Herndon in St. Louis, Ill. The first case is set for trial in March 2014.