Consumers filing a Pradaxa lawsuit have argued that drug’s manufacturers failed to warn the public about life-threatening bleeding risks.

Pradaxa (dabigatran) is an anticoagulant, or blood thinner. Like other blood-thinning drugs, Pradaxa may be prescribed to individuals at high risk of clotting or those whose blood clotting needs to be reduced to manage a condition.

When Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in 2010, it was advertised as a new alternative to warfarin. Warfarin has been the industry standard blood thinner for 60 years and is trusted by both patients and doctors. New blood thinners such as Pradaxa are often forced to compete with warfarin due to the drug’s established reputation.

Pradaxa advertising allegedly claimed it was superior to warfarin because it does not require the regular monitoring or intense dietary changes associated with warfarin. However, these benefits may not outweigh the drug’s risks.

Consumer reports suggest that Pradaxa may cause severe bleeding including internal bleeding, kidney bleeding, gastrointestinal bleeding, and brain hemorrhage. These may lead to complications including heart attack, stroke, and death.

Within the first three months that Pradaxa was on the market, the FDA reportedly received 307 reports of internal bleeding, gastrointestinal bleeding, and other complications associated with Pradaxa. In the drug’s first year on the market, the FDA received over 260 deaths associated with Pradaxa internal bleeding.

These high numbers of severe adverse events caused concern from customers, doctors, and the FDA. In December 2011, the agency notified the public of risks potentially associated with Pradaxa after they reviewed consumer reports regarding the issue.

According to an FDA safety alert from 2014, studies about Pradaxa’s safety profile reportedly showed that the drug is associated with a higher risk for gastrointestinal bleeding than warfarin. Although the two drugs had similar risks for myocardial infarction, consumers have reportedly expressed concern over Pradaxa’s alleged increased risk for a gastrointestinal bleed.

Often, a Pradaxa lawsuit will claim that Boehringer-Ingelheim failed to sufficiently warn the public that their drug may be associated with severe, irreversible bleeding events. Although a black box warning was added to the Pradaxa label in 2013, consumers claim that the drug manufacturer knew or should have known about the severe, unmanageable bleeding risk and warned consumers earlier.

Litigation concerning the drug may also take issue with the five years that the drug was on the market without any sort of antidote. Unlike warfarin, which can be counteracted by flooding the body with vitamin K, Pradaxa reportedly had no way to counteract severe bleeding until only recently.

In 2014, Boehringer-Ingelheim approved a $650 million Pradaxa lawsuit settlement to resolve claims against them. However, additional lawsuits have been filed in the years since, meaning that another lawsuit settlement may be possible. This would benefit Pradaxa claim plaintiffs who have taken legal action against the drug manufacturer and have not recovered compensation. Even if a Pradaxa lawsuit settlement is not reached, a favorable trial verdict could also provide an avenue for plaintiff compensation.