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New Pradaxa Lawsuit Added to MDL

News of more legal action related to pharmaceutical company Boehringer Ingelheim’s controversial Pradaxa anticoagulant has emerged from East St. Louis, Illinois. The Pradaxa lawsuit, filed on June 17th, was added to the ongoing multidistrict litigation (MDL 2385) now underway at the U.S. District Court for the Southern District of Illinois under the auspices of Judge David R. Herndon.

The 85-year-old woman who filed the latest Pradaxa lawsuit is from Dunellon, Florida. She was first prescribed the blood thinning medication in November 2010. In April, May and June of 2011, she  suffered gastrointestinal bleeding that required multiple blood transfusions.

The Pradaxa blood thinner injury described in her case closely resembles problems experienced by hundreds of individuals across the United States. More than 200 Pradaxa lawsuits are pending against Boehringer Ingelheim, but some legal experts predict as many as 4,000 may be filed at both state and federal levels over the next few years.

Pradaxa sales exceed $1 billion

Pradaxa has generated over a billion dollars for Boehringer Ingelheim in less than three years on the market. In 2013, sales of Pradaxa are projected to reach $603 million. The high sales were propelled by an aggressive marketing campaign, which is the source of much of the criticism now levelled at Boehringer Ingelheim.

According to the latest Pradaxa lawsuit, Boehringer Ingelheim spent $67 million promoting the product in 2010, and a staggering $464,000,000 in 2011. Part of the marketing was a “widely disseminated direct-to-consumer advertising campaign” designed to influence patients to ask their doctor about Pradaxa. The risks of Pradaxa bleeding were downplayed in the commercials.

Pradaxa was designed to treat atrial fibrillation, the most common type of irregular heartbeat. According to Boehringer Ingelheim’s website, around 1% of the world’s population is affected by atrial fibrillation, a condition known to cause as many as three million strokes per year.

Pradaxa lawsuits say alternatives are safer

Boehringer Ingelheim marketed their blood thinner as a safer, more convenient alternative to warfarin. They claimed the risk of major bleeding events was lower with Pradaxa, also making reference to the number of interactions warfarin has with other drugs as a reason to avoid it.

However, the latest Pradaxa lawsuit alleges that the drug does not compare favorably to warfarin, citing figures from a recent study that compared the two. The risk of major gastrointestinal bleeds with Pradaxa is 1.6%, compared to 1.1% with warfarin.

The lack of an antidote for Pradaxa makes any bleeding problem considerably more dangerous. This year, a review by The Institute for Safe Medication Practices (ISMP) found that the controversial medication generated 956 adverse event reports with the FDA in 2012, 178 of them reporting Pradaxa death. By contrast, warfarin generated 214 adverse event reports, with 14 of them reporting a death. During Pradaxa’s first year on the market, there were 2,367 adverse event reports in total.

Pradaxa MDL in early stages

The Pradaxa MDL established in Illinois is being overseen by U.S. District Judge Herndon. Proceedings are now set to begin in March 2014,  and include federal claims brought in California, Illinois, Delaware, Alabama and Connecticut, and other states. Judge Herndon has said the MDL is making ‘steady progress,’ but expects to see tens of thousands of documents submitted as evidence from both sides.