Lawsuit Says Pradaxa Was Over-Promoted Despite Bleeding Risks

Plaintiff Patricia Webster has filed a lawsuit against the manufacturers of Pradaxa on behalf of Charles Webster, alleging that the drug caused his death.

Charles Webster was prescribed Pradaxa for atrial fibrillation, after receiving promotional materials from the manufacturers. He experienced uncontrolled bleeding and died from this alleged Pradaxa side effect. The lawsuit alleges that Pradaxa caused the uncontrolled bleeding, that the manufacturers knew about this risk, and that the manufacturers failed to adequately protect patients from this risk.

The Pradaxa lawsuit states that the manufacturers were aware – or reasonably should have been aware of the risks associated with this drug. Unlike other anticoagulants (“blood-thinners”), Pradaxa has no reversal agent. This means that older anticoagulants’ effects can be reversed if uncontrollable bleeding occurs. However, with Pradaxa, physicians have very few options to reverse uncontrollable bleeding. The text of the Pradaxa lawsuit cites both peer-reviewed studies and postmarket surveillance that revealed the risk of bleeding. For example, the U.S. Food & Drug Administration (FDA) received 932 Serious Adverse Event reports between October 2010 and March 2011, including 500 reports of life-threatening bleeding and 120 deaths related to Pradaxa.

The Pradaxa lawsuit further alleges that despite these risks, the manufacturers aggressively promoted the drug, endangering the lives of consumers like Charles Webster. In 2011, the company reportedly spent 464 million dollars promoting Pradaxa, and conducted 1.5 million direct meetings with various healthcare professionals to market the drug. Additionally, some of these funds were used in direct-to-consumer marketing programs. Per the Pradaxa lawsuit, these programs did not mention that there is no reversal agent to the drug, and omitted other risks associated with Pradaxa. Charles Webster received information on the drug through one such program. Despite the risks associated with the drug, Pradaxa generated more than $1 billion in profits in 2011.

The Pradaxa lawsuit is formally titled Patricia A. Webster as Administrator of the Estate of Charles A. Webster v. Boehringer Ingelheim Pharmaceutics Inc., Case No. 3:13-cv-51580-DRH-SCW, in the U.S. District Court for the Southern District of Illinois. It has joined multidistrict litigation In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois.

Help for Pradaxa Bleeding Victims

If you or a loved one were medically diagnosed with internal bleeding problems after using Pradaxa, you may be able to take legal action against the drug’s manufacturer. Filing a Pradaxa lawsuit may help you recover compensation for medical bills, pain and suffering, and other damages. See if you qualify by filling out the short form at the Pradaxa Internal Bleeding Class Action Lawsuit Investigation.