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Tag: Pradaxa

  • $650 Million Settlement Reached in Pradaxa Lawsuit

    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

  • $650 Million Settlement: Pradaxa Maker Wants To Avoid Litigation

    A $650 million settlement is a hefty chunk of change, but it was a better outcome than the alternative for one drug maker.

    Boehringer Ingelheim, a German pharmaceutical company, was facing multiple lawsuits after families claimed Pradaxa, a blood thinner, caused severe and often fatal bleeding in those who took it. The drug is said to reduce the risk of stroke in those suffering from non-valvular atrial fibrillation. While internal bleeding is a side effect of this particular class of blood thinners, Boehringer Ingelheim claims that Pradaxa is safer than its closest contemporary – warfarin.

    Despite their claims, Boehringer Ingelheim chose to settle to avoid any lengthy litigation:

    “Time and again, the benefits and safety of Pradaxa have been confirmed,” said Desiree Ralls-Morrison, senior vice president and general counsel, Boehringer Ingelheim USA Corporation. “BI stands resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows BI to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients’ lives.”

    While Boehringer Ingelheim believes the settlement will satisfy most, it says that it’s ready to combat any plaintiffs that don’t take their offer:

    There are approximately 4,000 claims that the company seeks to resolve with this settlement. BI expects most, if not all, of the plaintiffs to accept the terms of the settlement and BI will vigorously defend against those who do not.

    It doesn’t seem that Boehringer Ingelheim is trying to sweep this issue under the rug, but it does seem to be moving the blame away from its drug. The company claims that its product is safe when taken properly. It also implores those taking the drug to consult a doctor before making any major changes to their intake:

    As with any anticoagulant, there needs to be a balanced consideration of stroke risk reduction and bleeding risk. Patients should not stop taking their anticoagulant medication without first talking to their health care providers. Discontinuing anticoagulation therapy puts a patient at increased risk of stroke.

    Here’s more information on Pradaxa and its effects:

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