California plaintiff Marvin K. is suing the German pharmaceutical giant Boehringer Ingelheim for the injuries he allegedly suffered from using Pradaxa. Marvin claims that as a direct result of using the defendant’s anticoagulant, he suffered life-threatening bleeding injuries and required emergency hospital intervention.

Pradaxa is one of the three new-generation anticoagulants available on the market. These drugs are prescribed to prevent stroke in patients with atrial fibrillation. Marvin was one of those high risk patients, according to his Pradaxa lawsuit, and he had been prescribed Pradaxa by his physician because it did not require frequent dose adjustments or frequent doctor visits.

The plaintiff’s lawyers argue that these regular checkups would have reduced the danger their client had apparently been in. According to the Pradaxa lawsuit, Marvin suffered an internal bleeding injury on July 12, 2012. He had to be hospitalized at the University of California Irvine Healthcare for 13 days. The lawsuit indicates that the bleeding injury had been worsened by Pradaxa because it decreased the plaintiff’s natural blood clotting function.

After recovering from the injuries, Marvin was then informed of Pradaxa’s tendency to cause bleeding incidents, which had not been mentioned on the product’s label. In response, Marvin is filing legal action against Boehringer for failing to protect him and other consumers who suffered similar side effects. At no point before or after his Pradaxa prescription did the defendant notify him of Pradaxa’s link to bleeding problems or of the fact that there is no reversal agent, the lawsuit claims.

The Pradaxa lawsuit further alleges that Boehringer had the civil responsibility to warn Martin and other Pradaxa patients of these possibilities because those patients rely on the given information of the label. Marvin insists that he never would have taken Pradaxa if he had known about the irreversible bleeding complication.

Marvin is suing Boehringer Ingelheim for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous drug. The claims include negligence, false advertising, concealing information, and misrepresenting a product.

This Pradaxa lawsuit is a part of the Pradaxa MDL known as In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois.

Overview of Pradaxa Complications

Pradaxa is a popular blood-thinner that is prescribed in America to reduce the risk of stroke or systemic embolism in patients who suffer non-valvular atrial fibrillation. It is manufactured by Boehringer Ingelheim, and it was the first drug in decades to break into the exclusive anticoagulant market.

Until Pradaxa’s approval by the FDA on Oct. 19, 2010, warfarin had been the only choice for patients in need of a blood thinner. Soon after Pradaxa’s release, it became a blockbuster drug in the United States with over $1 billion in profits during the fiscal year of 2011.

Unfortunately, it was alleged that this drug came with major design defects and complications soon after it was released. In contrast to its predecessor warfarin, Pradaxa did not require patients to frequently see their physicians and had no need for dose adjustments. However, another difference it has from warfarin is that Pradaxa has no reversal agent in the case of an internal bleeding event, which puts these patients at risk. This fact was not mentioned on Pradaxa’s warning label, resulting in mass litigation against Boehringer.

This outcry eventually led the FDA to issue a public warning in 2011 regarding Pradaxa complications, warning patients that the drug could cause irreversible bleeding events. By the end of that year, at which time the drug had only been available for 14 months, the FDA received approximately 500 reports of deaths that were allegedly caused by Pradaxa.

With this complication out in the open, thousands of patients have filed Pradaxa lawsuits against Boehringer Ingelheim for failing to protect them against Pradaxa complications. Additionally, legal experts accuse the company of deliberately concealing this information in order to protect the market value of Pradaxa.