Pradaxa Death Lawsuit Added to MDL

Boehringer Ingelheim’s controversial Pradaxa anticoagulant is the subject of new litigation. The plaintiff is filing the lawsuit on behalf of her deceased husband, who allegedly died as a result of using the product. The Pradaxa death lawsuit, filed on June 21, has been added to the ongoing multidistrict litigation (MDL 2385) in the U.S. District Court for the Southern District of Illinois. 

The plaintiff’s husband had atrial fibrillation and was prescribed Pradaxa toward the end of 2011. In January 2012, he was admitted to a Las Vegas hospital after showing signs of internal bleeding. Doctors determined that he had experienced acute gastrointestinal hemorrhaging, and that it was exacerbated by his use of Pradaxa. Despite several blood transfusions, the man died of a massive heart attack on April 29, 2013.

The Pradaxa bleeding problems described in the lawsuit closely resemble the experiences of hundreds of individuals all over the country, many of whom are involved in the MDL.

Pradaxa has earned more than a billion dollars for Boehringer Ingelheim during its three years on the market. Sales are anticipated to exceed $600 million this year alone, thanks largely to a costly advertising campaign. The company’s aggressive marketing strategies have attracted much criticism from lawyers and medical experts.

According to court documents from the Pradaxa death lawsuit, Boehringer Ingelheim spent $67 million promoting the product on its release in 2010, and $464 million in 2011. One of the most contentious elements of Boehringer Ingelheim’s promotion of the drug was a “widely disseminated direct-to-consumer advertising campaign” encouraging patients to ask their doctor about Pradaxa. The company is also accused of downplaying the potential severity of Pradaxa bleeding problems.

Numerous studies condemn Pradaxa

Central to the marketing of Pradaxa was the drug makers’ claim that it was a safer alternative to the much older blood thinner warfarin. Boehringer Ingelheim claimed the risk of major bleeding problems was lower with Pradaxa.

But the Pradaxa death lawsuit recently added to the MDL claims it is not preferable to  warfarin, citing figures from a recent study that shows the risk of major gastrointestinal bleeding with Pradaxa is 1.6%, compared to warfarin’s 1.1%. Unlike warfarin, Pradaxa has no antidote, which increases the severity of internal bleeding and the chance of death. Plaintiffs are holding Boehringer Ingelheim liable for failing to warn of life-threatening Pradaxa side effects.

A number of international studies support the allegations. In 2011, New Zealand’s pharmaceutical regulatory authority issued a warning that Pradaxa carries a greater risk of gastrointestinal bleeds than warfarin. A second report indicated that, out of 10,000 New Zealanders who had used the drug, 78 had suffered severe Pradaxa bleeding problems. Of those, 55 required hospital treatment and ten had resulted in death.

In March 2012, the New England Journal of Medicine published two letters from doctors in New Zealand expressing concern about Pradaxa bleeding problems. In one letter, the physicians said “the potential risks of this medication are not generally appreciated. The serious consequences of a lack of an effective reversal agent should not be underestimated.”

A 2013 review by The Institute for Safe Medication Practices (ISMP) stated that Pradaxa had generated 956 adverse event reports during 2012, 178 of them reporting Pradaxa-related deaths. Warfarin generated 214 adverse event reports, with 14 of them reporting a death.

700 lawsuits pending in Pradaxa MDL

Judge David R. Herndon is presiding over the Pradaxa litigation in Illinois, which has consolidated an estimated 700 cases alleging similar side effects and injuries. In addition to the Pradaxa death lawsuit filed by the recently bereaved Nevada woman, cases have emerged from California, Delaware, Alabama and Connecticut.