Pradaxa Lawsuits Allege Pradaxa Bleeding Risk, Insufficient Warnings

Hartford, CTEven though Pradaxa and a competitor were brought to market as an easier-to-manage alternative to warfarin, previously the gold standard for blood thinning, no one disputes the fact that all anti-coagulants carry a risk for bleeding events. However, it is alleged in Pradaxa lawsuits that some blood thinners carry a greater risk for bleeding events than others.

Pradaxa was the first of two second-generation anti-coagulants approved for the US market. Both were deemed safe and effective for the treatment of atrial fibrillation, a heart condition that is known to increase the risk of blood clots that could, in turn, lead to a stroke. Pradaxa, akin to its competitor which came into the market at a later date, claimed to be easier to manage and less cumbersome than warfarin, with less monitoring required.

Both second-generation products – including Pradaxa – were approved without benefit of a reversing agent that might otherwise be available to doctors in order to stem a serious bleeding event.

The blood thinning properties of warfarin can be reversed in most patients with an immediate infusion of Vitamin K, a tool in a physician’s tool box that’s been available since warfarin first became indicated for blood thinning more than five decades ago. It’s possible that patients, and even their caregivers assumed that new products could be reversed in the same fashion, without visiting the Pradaxa warning label which Boehringer Ingelheim Pharmaceuticals Inc., the manufacturer of Pradaxa, insists was explicit in terms of risk for bleeding and the lack of an antidote.

In October, Boehringer moved to have a Pradaxa lawsuit dismissed on grounds that warning labels were more than adequate (Liu et al. v. Boehringer Ingelheim Pharmaceuticals Inc. et al., Case No. 14-cv-13234-WGY, in the US District Court for the District of Massachusetts).

A study published in January 2012 in the Archives of Internal Medicine suggested a link between the use of Pradaxa and a slightly higher risk of Pradaxa heart attack or acute coronary syndrome when compared with similar medicines. Dabigatran Pradaxa has been linked to somewhere between 50 and 256 deaths. Boehringer itself claims that 260 Pradaxa deaths worldwide have been caused from fatal Pradaxa bleeding associated with Pradaxa use and Pradaxa side effects.

Meanwhile, the Pradaxa lawsuits keep coming. Last year a Pradaxa lawsuit was filed in Connecticut Superior Court in the Judicial District of Hartford (Craig Niedermann, as Personal Representative of the Estate of Marvene Niedermann, Decedent,
Plaintiff, vs. Boehringer Ingelheim Pharmaceuticals, Inc. and
Boehringer Ingelheim International GMBH).