Pradaxa lawyers at Pintas & Mullins Law Firm report that the pharmaceutical litigation is moving forward in the U.S. District Court of Southern Illinois. To date, more than 170 lawsuits have been filed against Pradaxa manufacturer Boehringer Inhelheim.
Pradaxa is a blood-thinning anti-stroke drug which eclipsed over $1 billion in sales in 2011. Many experts are projecting the Pradaxa litigation to be the next blockbuster payout, and one of the biggest mass cases in the history of the US. This is because the adverse events associated with Pradaxa are inordinately dangerous and severe, yet the drug is taken twice a day by millions of Americans. In 2011 alone, nearly 550 Pradaxa deaths were reported to the FDA.
The anticoagulant drug was approved in 2010 for stroke-prevention in patients with irregular heartbeat. Its predecessor, Warfarin, dominated the anti-stroke market since the 1950s, although it required weekly medical exams and adherence to a specific diet. Upon its release, Pradaxa seemed too good to be true; it did not require as many exams and did not require a special diet. For many patients, however, it was too good to be true and these patients soon came face-to-face with this devastating reality.
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Boehringer Ingelheim spent more than $450 million in 2011 to promote Pradaxa. In the first three months on American markets, however, the FDA was swamped with adverse event reports from the drug. So many, in fact, that Pradaxa reports accounted for more than 98% of all adverse complaints in those three months.
Both Warfarin and Pradaxa carry the risk of hemorrhaging and internal bleeding. These effects are easily counteracted in Warfarin patients with high doses of Vitamin K. Unfortunately, this does not work in those taking Pradaxa, and hundreds of patients have bled to death because no antidote yet exists to stop bleeding caused by Pradaxa.
Other complaints include reports of ineffectiveness, ultimately leading to life-threatening blood clots, and increased risk of hemorrhages, particularly in the elderly and those with impaired kidneys. Pradaxa is eliminated from the body through the kidneys and some are claiming that the drug should never have been approved for those with impaired kidney function.
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According to an Institute for Safe Medication Practices report, in cases of hemorrhage, Pradaxa is five times more likely to result in death than Warfarin. The report also highlighted that previous studies underestimated the use of anticoagulant therapy, and Pradaxa may have additional risks that are not yet fully known or understood. If that wasn’t bad enough, in 2012, a study by the Cleveland Clinic found Pradaxa to have an increased risk of heart attack by 33% compared to patients on another blood-thinner, like Warfarin, or a placebo.
Just over a year after the FDA approved Pradaxa, the agency launched a safety review evaluating the reports of bleeding events. Boehringer itself is also in the midst of an evaluation, investigating the hundreds of Pradaxa death reports. The FDA evaluations are ongoing, with multiple sources of data examining the rates of gastrointestinal bleeding and brain hemorrhaging in Pradaxa patients compared to Warfarin patients.
A judicial panel was recently organized in Southern Illinois to centralize the multi-district litigation. Plaintiffs argue that Boehringer did not adequately inform physicians of the risks of excessive bleeding and other injuries associated with Pradaxa, specifically that there is no reversing agent. Southern Illinois was chosen because of the numerous actions pending in that district as well as its central location within the US. The selected Judge Herndon previously presided over the Yaz and Yasmin multi-district litigation case.
Regulators in Europe have already required Boehringer to add warnings on Pradaxa’s label about the risks of excessive, irreversible bleeding. Pradaxa attorneys at Pintas & Mullins Law Firm urge anyone experiencing complications from Pradaxa to contact your physician immediately. We are currently reviewing potential Pradaxa injury cases.