It hard to imagine the Food and Drug Administration (FDA) continues to stand by the safety of the anticoagulant Pradaxa even as the number of defective drug cases continue to rise at a startling pace.
A special federal court that has consolidated cases in the Southern District of Illinois had 1,172 cases filed against German drugmaker Boehringer Ingleheim last July, however by the end of October, the MDL reported there had been a 40 percent increase in Pradaxa actions filed. The multidistrict litigation (MDL) is #2385 Pradaxa Product Liability Litigation.
Expect “bellwether” trials to begin in Illinois next August to test legal arguments before a jury and get an indication of how these cases will be perceived. A series of losses and Boehringer may decide to offer a settlement. On the other hand, if the defendant makes a good impression to juries, litigation could continue into the near future.
Meanwhile Pradaxa, also known by its generic name dabigatran, remains on the market. It is prescribed to patients to reduce the risk of blood clots and stroke in those with non-valvular atrial fibrillation (AF). AF results in the upper chamber of the heart beating irregularly and it is a common condition. Approximately 2.7 million Americans are living with the symptoms of AF.
The product liability claims say the drug is defective in its design, its manufacture and/or its marketing. Not only have there been at least 500 deaths reported to the FDA since the drug was approved in 2010, but the current issue of Quarter Watch, a publication of the Institute of Safe Medication Practices says Pradaxa, as well as warfarin (Coumadin), were the two drugs leading adverse event reports to the FDA in 2012.
Consider the extra risk with Pradaxa. Coumadin, the popular anticoagulant, can be reversed with a dose of vitamin K. With Pradaxa there is no such way to reverse the bleeding caused by Pradaxa.
The pharmaceutical manufacturer knows there is a problem.
Boehringer Ingelheim announced the release of new data at the European Society of Cardiology in Amsterdam this fall. While expressing a commitment to “advancing the body of information related to stroke and to constantly search for new and innovative ways to improve the lives of patients with cardiovascular disorders,” Boehringer said it supported new research on a reversal agent in rats and presumably in humans some day.
Still, last year Pradaxa captured about 28 percent of the market that used to belong to warfarin producing more than $1 billion in sales in two years.