We’ve known for some time that Pradaxa has problems—this drug, intended to replace the time-tested blood thinner Warfarin (Coumadin), has been shown to cause internal bleeding and hemorrhaging. Unlike Warfarin, the bleeding cannot be quickly countered, which can cause death in serious cases. There were at least 260 deaths of people on Pradaxa between October 2010 and November 2011, which were confirmed by the drug’s manufacturer.
But when a drug is not properly tested and evaluated for safety before it comes on the market, you often see more than one problem with the drug. Now, new information has come out showing that patients with artificial heart valves are particularly at risk for Pradaxa injuries.
The warning comes from the FDA, which advises that a European clinical trial called RE-ALIGN was stopped mid-study because people with mechanical heart valves were more likely to experience strokes, blood clots and heart attacks, as compared to Warfarin users. The FDA is going so far as to require a labeling change warning doctors and patients that Pradaxa is contraindicated for patients with prosthetic heart valves.
Importantly, the FDA is not recommending Pradaxa use in patients with other types of heart valves called bioprosthetic valves. Those are made with natural biological tissue, but the effects of Pradaxa have not been specifically studied for those patients.
Pradaxa Lawsuit History
Pradaxa is an anticoagulant medication used to prevent blood clots and reduce the risk of stroke in patients with certain heart conditions. The drug was approved by the FDA in 2010 and quickly became a popular alternative to older anticoagulants like warfarin because it required less monitoring and had fewer dietary restrictions.
However, soon after Pradaxa hit the market, reports of serious bleeding events began to emerge. Almost immediately, patients reported uncontrollable bleeding that was difficult to stop, and some suffered fatal bleeding events. In response to these reports, the FDA issued a safety communication in 2011, warning patients and healthcare providers about the risk of serious bleeding with Pradaxa.
The first Pradaxa lawsuit was filed in 2012. Many more followed. Plaintiffs alleged that the drug’s manufacturer, Boehringer Ingelheim, failed to warn them about the risk of bleeding and did not adequately test the drug before bringing it to market.
The Pradaxa class action lawsuit ultimately included thousands of lawsuits that had been filed by patients or their families who alleged that they had suffered serious bleeding events while taking the drug. The lawsuits were consolidated before a single judge, who oversaw pretrial proceedings such as discovery, motion practice, and bellwether trials. The results of those trial were mixed. Plaintiffs won some trials – some survived the appellate process and some did not – and lost some trials.
In 2014, Boehringer Ingelheim agreed to pay $650 million to settle about 4,000 lawsuits related to Pradaxa. In addition to the settlement, Boehringer Ingelheim also agreed to conduct additional studies to investigate the bleeding risks associated with Pradaxa. The company also agreed to provide additional warnings about the risk of bleeding and to update the drug’s label.
The Pradaxa MDL was officially closed in 2018, after all of the remaining cases had been resolved, send back to their home jurisdictions, or dismissed.
It Was Always a Failure to Warn Lawsuit
Lots of counts were pled in Pradaxa lawsuits. But it always came down to failure to warn.
A “failure to warn” claim is a type of legal claim that can be made in product liability cases. In the context of the Pradaxa litigation, a failure to warn claim alleges that the manufacturer of Pradaxa, Boehringer Ingelheim, failed to provide adequate warnings to patients and doctors (more healthcare providers than patients, actually) about the potential risks associated with the drug.
Specifically, plaintiffs in Pradaxa lawsuits alleged that Boehringer Ingelheim did not adequately warn about the risk of serious bleeding events associated with the drug. Plaintiffs argued that the company knew or should have known about the bleeding risks, but did not provide adequate warnings to patients or healthcare providers.
Pradaxa lawsuits died with the settlement. Same drug, same risks. So why? The Pardaxa lawsuits were always a warnings case. No one was calling for a Pardaxa recall. Just warn doctors and patients of the risk and let them decide. Boehringer Ingelheim did that. Litigation over. (It also did not hurt that a Pradaxa reversal agent, Praxbind, came out in 2016 to stop Pradaxa bleeding events for many patients.