According to reports, Pradaxa, a blood thinner, has led to thousands of lawsuits filed against the drug’s manufacturer, Boehringer Ingelheim Pharmaceuticals.

Patients take issue with the fact that the blood thinner did not have an antidote for serious Pradaxa internal bleeding events until 2015.

Pradaxa, also known as dabigatran, was approved in 2010 by the U.S. Food and Drug Administration. It has, however, allegedly been associated with thousands of serious adverse side effects, some of which have been linked to hundreds of fatalities.

An MDL, or multidistrict litigation, was filed which consolidated all the patient lawsuits filed against the manufacturer into one consolidated action in 2012.

As a result of alleged reports of Pradaxa internal bleeding, Boehringer Ingelheim, the drug’s manufacturer, had agreed to settle the 4,000 lawsuits against the company by paying $650 million in May 2014.

Coincidentally, the company was also obligated to pay the U.S. government and several states $95 million to resolve off-label and kickback charges of its other medications in October 2012, only eighteen months prior.

According to Attorney General Eric T. Schneiderman, he had announced that the manufacturer had “agreed to pay $95 million to resolve charges that the company engaged in various illegal schemes related to the marketing of the drugs Aggrenox, Atrovent, Combivent and Micardis.”

The FDA, moreover, only approved Pradaxa’s monoclonal antibody, Praxbind, in October 2015. Designed to reverse the anticoagulant effects of Pradaxa, it was also developed by Boehringer Ingelheim Pharmaceuticals.

The FDA had first approved Pradaxa to help prevent the formation of blood clots and reduce the risks of strokes in patients who have the medical condition called atrial fibrillation. It is also used to treat blood clots in the veins of legs, called DVT or deep vein thrombosis, and blood clots forming in the lungs called pulmonary embolism.

Additional information about Pradaxa internal bleeding includes that prior to its approval and release onto the market, warfarin had been the popular and prescribed drug to patients with these medical conditions. The difference between the two is that unlike warfarin, Pradaxa does not require regular blood monitoring. With Pradaxa’s onset and theoretical ease of use, by 2010 approximately 725,000 patients had been prescribed and treated with the blood thinner.

Since, however, no reversal agent for Pradaxa internal bleeding had been approved and released to the market, there have been thousands of Pradaxa internal bleeding events, serious adverse side effects, and fatalities as a result. This was before the release of Praxbind.

A study conducted by the British Medical Journal (BMI), had announced a report stating that the drug company had “withheld important analyses” of Pradaxa. The study, published in July 2014, iterates that among other withheld information, the company “withheld analyses that calculated how many major bleeds dose adjustment could prevent.”

The study added that “the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible.”