Boehringer Ingelheim Pharmaceuticals this week agreed to a settlement in the multi-district litigation over the drug Pradaxa. The company has agreed to pay $650 million to settle the lawsuits. Much of that money will be used to compensate patients who claim they were injured by Pradaxa.
Around 1,600 people had filed individual lawsuits against Boehringer Ingelheim over Pradaxa as of 2012. In August of that year a federal court consolidated the claims into a multi-district litigation, a type of proceeding that is typically quicker than a class action lawsuit and in which one judge is able to decide on many similar claims together. In addition, four state proceedings had been filed over the drug in California, Missouri, Delaware, and Connecticut. In total, around 4,000 Americans filed lawsuits against Boehringer Ingelheim claiming to have been harmed by Pradaxa.
“We are pleased that today’s settlement will bring justice and financial assistance to those hurt while taking Pradaxa," said Mikal Watts, a lawyer appointed co-lead counsel for all plaintiffs by the judge in the case. "We are proud of the settlement we have achieved, congratulate the company on doing the right thing, and look forward to distributing these funds to our clients as expeditiously as possible.”
Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in 2010 as an anticoagulant. Like other anticoagulants, Pradaxa was used as a blood thinner for patients at risk for stroke. Also like other anticoagulants, Pradaxa's most common side effect is bleeding - particularly gastrointestinal bleeding. Elderly patients taking the drug were found by the FDA to die more often due to the drug's side effects.
The lawsuits claimed that Boehringer Ingelheim knew the drug was more dangerous than previously realized. Court documents showed that the company failed to inform the FDA that Pradaxa is more dangerous than pre-approval studies indicated and that company executives tried to silence an internal study that could have hurt sales of the drug.
Image via the National Institutes of Health