In the midst of the anticoagulant bleeding risk litigation and the pending approval of a bleeding antidote, Boehringer Ingelheim Pharmaceuticals has made another major Pradaxa announcement. The German pharmaceutical giant is now seeking FDA approval to treat patients who have recently undergone hip replacement surgery for deep vein thrombosis (DVT) and pulmonary embolism (PE) with Pradaxa.

Boehringer Ingelheim recently submitted a supplemental new drug application (sNDA) to the FDA and hopes to be approved to treat blood-clotting in patients who have recently undergone hip replacement surgery. If the FDA approves this request, Pradaxa will officially be approved to treat four conditions, with the others being: stroke, atrial fibrillation, and blood clotting in patients who underwent knee replacement surgery.

Spectating legal experts are not surprised by this development, as the recent litigation drama surrounding Pradaxa and the other new-generation anticoagulants has been mostly negative. Essentially, the goal of the blood-thinner manufacturers is to not only ensure its market value, but to continuously maintain that the benefits of their drug outweigh the risks.

Recently, Boehringer Ingelheim Pharmaceuticals settled a majority of its Pradaxa lawsuits in May 2014 for $650 million, which paid out approximately 4,000 cases that had been filed in state and federal courts; the Pradaxa settlement value was approximately $160,000 per lawsuit. These Pradaxa lawsuits alleged that Pradaxa carried a high risk of uncontrollable internal bleeding, but had failed to mention the fact on the drug’s label.

After numerous severe injury and death claims were filed in regards to Pradaxa bleeding, they were consolidated into one multidistrict litigation (MDL) in August 2012 in the U.S. District Court of Southern Illinois before Judge David R. Herndon. Despite the massive Pradaxa settlement and the thousands of Pradaxa bleeding claims, Boehringer Ingelhim Pharmaceuticals denies any misconduct or unlawful activity, stating that the settlement will allow the company to move forward and no longer be distracted by the litigation.

Earlier, the German pharmaceutical company announced that it had a Pradaxa bleeding antidote on the FDA’s fast-track approval process, which will hopefully prevent any future internal bleeding emergencies. With this new use approval process started, Boehringer Ingelheim Pharmaceuticals is aiming to completely move past the legal issues and focus on the future of Pradaxa.

Overview of New Anticoagulant Complications

Unfortunately for Boehringer Ingelheim Pharmaceuticals, new generation anticoagulants have disappointed many patients and the medical community. Almost as soon as Pradaxa litigation died down, Xarelto was there to take its place, as its manufacturer also faces thousands of lawsuits concerning bleeding claims. Xarelto was approved for the market a year after Pradaxa and was a joint drug effort by Bayer Pharmaceuticals and Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. The pharmaceutical companies created Xarelto to be a direct competitor to Pradaxa, after seeing the success Pradaxa brought to Boehringer Ingelheim Pharmaceuticals.

It is important to note that Pradaxa was the first anticoagulant to be approved since Warfarin in the United States. So when Pradaxa was approved for market, it was considered a huge success in the pharmaceutical community, as patients now had options for which anticoagulant they would like as a blood thinning treatment. Not only was Pradaxa advertised to be more efficient than Warfarin, but it was also supposedly hassle-free for the patients.

Unlike Warfarin, Pradaxa did not require patient to undergo frequent dose adjustments and doctor appointments; however, Pradaxa also lacked a certain safety feature. In the case of a Warfarin internal bleeding even, a doctor could apply Vitamin K to halt the complication; the lack of a Pradaxa antidote has allegedly caused severe injuries in numerous patients.

However instead of warning patients of this internal bleeding danger, Boehringer Ingelheim allegedly chose to omit this information from Pradaxa’s warning label. Patients claim that it was because the company was trying to preserve the product’s market value, prioritizing the success of their drug over patient safety.