{"id":353333,"date":"2016-04-04T10:46:58","date_gmt":"2016-04-04T15:46:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/pradaxa.html"},"modified":"2024-02-06T18:08:33","modified_gmt":"2024-02-06T23:08:33","slug":"pradaxa","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/pradaxa.html","title":{"rendered":"Pradaxa Legal Information"},"content":{"rendered":"\n<div class=\"wp-container-core-columns-is-layout-9d6595d7 fl-sectionWithSidebar fl-container fl-flex fl-flex-wrap fl-gap30\">\n<div class=\"fl-page-articles fl-section-main fl-section-main-full-width\"><h1 class=\"fl-no-margin-top\">Pradaxa Legal Information<\/h1>\n\n<section class=\"fl-gutenberg-byline\">\n    <div class=\"fl-gutenberg-byline-content\">\n                    By <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/christie-nicholson-j-d\/\">Christie Nicholson, J.D.<\/a> | Legally reviewed by <a\n                href=\"https:\/\/www.findlaw.com\/company\/our-team\/oni-harton-j-d\/\">Oni Harton, J.D.<\/a>\n                | Last reviewed\n        <time>\n                            February 06, 2024\n                    <\/time>\n    <\/div>\n\n    \n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-legally-reviewed\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Legally Reviewed\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>This article has been written and reviewed for legal accuracy, clarity, and style by <a href=\"https:\/\/www.findlaw.com\/company\/our-team.html\">FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with <a href=\"https:\/\/www.findlaw.com\/company\/company-history\/editorial-policy.html\">our editorial standards<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n\n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-fast-checked\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Fact-Checked\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>The last updated date refers to the last time this article was reviewed by FindLaw or one of our <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/contributing-authors.html\">contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please <a href=\"https:\/\/lawyers.findlaw.com\/?fli=bylinelink\" target=\"_blank\" rel=\"noopener\">contact an attorney in your area<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n<\/section>\n\n\n    <div class=\"fl-callout-text article-blockquote\">\n        <p>Pradaxa is a blood thinner approved to treat atrial fibrillation and prevent blood clots. However, it has been linked to serious side effects like bleeding, strokes, and heart attacks. Thousands of patients have filed lawsuits against its manufacturer, Boehringer Ingelheim, alleging failure to warn about these risks.<\/p>\n\n    <\/div>\n\n\n\n<p>Millions of Americans suffer from an irregular heartbeat. The medical name for this condition is\u00a0<a href=\"https:\/\/www.heart.org\/en\/health-topics\/atrial-fibrillation\/what-is-atrial-fibrillation-afib-or-af\" target=\"_blank\" rel=\"noopener\">atrial fibrillation<\/a>\u00a0(AF). Many patients with AF take anticoagulants (blood thinners) to reduce the risk of:<\/p>\n<ul>\n<li>Blood clots<\/li>\n<li>Heart disease<\/li>\n<li>Pulmonary embolism<\/li>\n<li>Stroke<\/li>\n<\/ul>\n<p>Blood thinners like Pradaxa (dabigatran etexilate) help reduce the risks of AF.<\/p>\n<p>The U.S. Food and Drug Administration (FDA) <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2010\/022512orig1s000toc.cfm\" target=\"_blank\" rel=\"noopener\">approved Pradaxa in October 2010<\/a>. The drug&#8217;s manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc., obtained approval from FDA to distribute the drug in the United States. The FDA approved the medicine to help prevent <a href=\"https:\/\/www.webmd.com\/dvt\/default.htm\" target=\"_blank\" rel=\"noopener\">deep vein thrombosis<\/a>\u00a0(DVT) and blood clots in the body and lungs.<\/p>\n<p>Since its approval, Pradaxa has become a popular alternative to the long-used anticoagulant <a href=\"https:\/\/www.webmd.com\/drugs\/2\/drug-3949\/warfarin-oral\/details\" target=\"_blank\" rel=\"noopener\">warfarin<\/a>. Unlike warfarin, Pradaxa doesn&#8217;t require regular monitoring tests or special dietary restrictions.<\/p>\n<p>But researchers have published reports questioning the safety of Pradaxa. Many Pradaxa users have complained of health complications. In extreme cases, these complications have reportedly resulted in death. As a result, many patients have filed lawsuits against Boehringer Ingelheim.<\/p>\n<p>This article outlines the legal issues regarding the drug Pradaxa. You&#8217;ll also learn about the drug&#8217;s adverse side effects and health risks.<\/p>\n<p>Drug manufacturers have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you have been harmed by Pradaxa or another drug, you have legal options. Contact a <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a> near you to determine if you have a valid claim.<\/p>\n<h2>Possible Health Complications From Taking Pradaxa<\/h2>\n<p>Most drugs carry side effects and potential health risks. Some\u00a0<a href=\"http:\/\/www.nlm.nih.gov\/medlineplus\/druginfo\/meds\/a610024.html\" target=\"_blank\" rel=\"noopener\">Pradaxa<\/a>\u00a0patients reported serious bleeding-related injuries. Others have complained about the following:<\/p>\n<ul>\n<li>Gastrointestinal bleeding<\/li>\n<li>Severe hemorrhaging<\/li>\n<li>Strokes<\/li>\n<li>Heart attacks<\/li>\n<li>Other serious complications and injuries<\/li>\n<\/ul>\n<p>These reports prompted government reviews, medical studies evaluating the drug&#8217;s safety and effectiveness, and thousands of Pradaxa lawsuits.\u00a0<\/p>\n<h2>Pradaxa vs. Coumadin<\/h2>\n<p>After the FDA approved Pradaxa, the drugmaker enjoyed immediate success. Boehringer Ingelheim had global sales of $1 billion in 2011 alone. The primary reason for this success is the drug <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/deceptive-marketing-of-drugs-and-the-failure-to-warn.html\">company&#8217;s advertisements<\/a> portraying Pradaxa as a better treatment for AF than traditional Coumadin medication (warfarin).<\/p>\n<p>Coumadin can be inconvenient because patients must attend weekly checkups. They must also comply with strict dietary restrictions. Pradaxa is as effective as Coumadin but doesn&#8217;t require frequent checkups. Nor does it carry the extensive dietary restrictions due to excessive levels of Vitamin K.<\/p>\n<h2>Pradaxa&#8217;s Common Side Effects<\/h2>\n<p>Almost all prescription medications have side effects. Most are minor and unpleasant. Common\u00a0<a href=\"https:\/\/www.webmd.com\/drugs\/2\/drug-154839-1122\/pradaxa-oral\/dabigatran-oral\/details\" target=\"_blank\" rel=\"noopener\">side effects\u00a0of the blood thinner Pradaxa<\/a> include:<\/p>\n<ul>\n<li>Indigestion<\/li>\n<li>Nausea<\/li>\n<li>Hemorrhage\/bleeding events<\/li>\n<li>Gastritis<\/li>\n<li>Bruising<\/li>\n<li>Gastrointestinal ulcer<\/li>\n<li>Vomiting<\/li>\n<\/ul>\n<p>Patients allergic to Pradaxa may experience rash, itching, and hives.<\/p>\n<h2>Serious Side Effects of Pradaxa<\/h2>\n<p>The most common risk of Pradaxa is a bleeding risk. This is true for most anticoagulants. But there are other adverse health risks for patients taking this drug. In 2011, the\u00a0<a href=\"https:\/\/www.ismp.org\/\" target=\"_blank\" rel=\"noopener\">Institute for Safe Medication Practices<\/a>\u00a0(ISMP) found that Pradaxa was one of the most dangerous drugs on the market.<\/p>\n<p>In addition to Pradaxa bleeding events, Pradaxa can also cause heart attacks. According to a 2012 study by the\u00a0<a href=\"https:\/\/www.fiercepharma.com\/pharma\/study-flags-risk-of-heart-attack-acs-pradaxa-patients\" target=\"_blank\" rel=\"noopener\">Cleveland Clinic<\/a>, Pradaxa users have a 33% higher risk of heart attack as compared to warfarin users.<\/p>\n<p>These health risks can be life-threatening. Seek immediate medical attention if you experience hemorrhaging, uncontrolled bleeding, or heart issues.<\/p>\n<p>In November 2012, the FDA <a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-drug-safety-communication-pradaxa-dabigatran-etexilate-mesylate-should-not-be-used-patients\" target=\"_blank\" rel=\"noopener\">released an official statement<\/a> declaring that Pradaxa (dabigatran etexilate) doesn&#8217;t pose a higher risk of bleeding than its competitor, warfarin. But the FDA also announced that it would closely monitor Pradaxa. The agency also said it would conduct follow-up studies to assess the chances of bleeding complications.<\/p>\n<h2>Certain Patients Should Not Take Pradaxa<\/h2>\n<p>Before taking Pradaxa, tell your doctor about any medical condition you may have. Depending on your health, you may want to avoid drugs like Pradaxa.<\/p>\n<p>People with a mechanical heart valve should avoid taking Pradaxa. The same is true for patients with the following:<\/p>\n<ul>\n<li>History of stroke<\/li>\n<li>Recent surgery<\/li>\n<li>Liver disease<\/li>\n<li>Kidney disease<\/li>\n<li>Bleeding disorders<\/li>\n<li>History of falls<\/li>\n<\/ul>\n<p>Your doctor should check for any potential health risks and adverse events. If they don&#8217;t, they may be liable for\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/medical-malpractice\/medical-malpractice-liability.html\">medical malpractice<\/a>.<\/p>\n<h2>Pradaxa Lawsuits and Litigation<\/h2>\n<p>Many patients have filed product liability lawsuits against Boehringer Ingelheim for Pradaxa complications. Under\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/what-is-product-liability.html\">product liability law<\/a>, drug manufacturers must ensure their products are safe. Some plaintiffs have accused Boehringer of failing to adequately warn them about the risk of bleeding with Pradaxa.<\/p>\n<p>Plaintiffs have also filed <a href=\"https:\/\/www.findlaw.com\/hirealawyer\/choosing-the-right-lawyer\/wrongful-death-plaintiff.html\">wrongful death lawsuits<\/a> against the drugmaker. These lawsuits allow surviving family members to sue the party responsible for their loved one&#8217;s death.<\/p>\n<p>In a wrongful death suit, plaintiffs can recover the following compensation:<\/p>\n<ul>\n<li>Medical or funeral expenses<\/li>\n<li>Loss of the deceased&#8217;s financial support<\/li>\n<li>Loss of companionship or emotional support<\/li>\n<\/ul>\n<p>Thousands of patients have already filed Pradaxa lawsuits. By 2014, there were more than 4,000 lawsuits against Boehringer Ingelheim. Plaintiffs alleged that the drug company\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/defects-in-warnings.html\">failed to warn<\/a>\u00a0doctors and patients about the increased risk of bleeding-related injuries.<\/p>\n<p>They also contend that the company\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/defects-in-design.html\">defectively designed<\/a>\u00a0Pradaxa in a manner that made the drug unsafe for patients. For the first five years the drug was on the market, there was no antidote to stop uncontrollable bleeding.<\/p>\n<p>In 2014, the drug company\u00a0<a href=\"https:\/\/www.consumersafety.org\/drug-lawsuits\/pradaxa\/\" target=\"_blank\" rel=\"noopener\">settled most of these cases<\/a>. The company also set aside millions of dollars for future patients who may suffer injuries after taking Pradaxa.<\/p>\n<h2>What To Do if You Become Sick After Taking Pradaxa<\/h2>\n<p>Patients who suffer injuries after taking Pradaxa have legal options. You can sue the drug manufacturer. Usually, your attorney settles these cases with the drugmaker&#8217;s insurance carrier.<\/p>\n<p>Patients who successfully sue can\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/accident-injury-law\/economic-recovery-for-accidents-and-injuries.html\">recover compensation<\/a>\u00a0from the manufacturer. This includes:<\/p>\n<ul>\n<li>Medical bills<\/li>\n<li>Lost wages<\/li>\n<li>Future lost income<\/li>\n<li>Pain and suffering<\/li>\n<\/ul>\n<p>The best way to know if you have a legal claim is to talk to a lawyer\u00a0near you. Most firms offer a free case evaluation to new clients. If your attorney determines your case is worth pursuing, they can file suit.<\/p>\n<p>FindLaw&#8217;s directory of <a href=\"https:\/\/lawyers.findlaw.com\/personal-injury-defense\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">personal injury attorneys<\/a> can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys\u2019 experience with dangerous drug litigation.<\/p>\n\n\n<div class=\"was-this-helpful\">\n    <div\n            class=\"was-this-helpful__question-container\"\n            aria-labelledby=\"was-this-helpful__question\"\n            role=\"group\"\n    >\n        <span\n                id=\"was-this-helpful__question\"\n                class=\"was-this-helpful__question fl-text-lg-bold\"\n        >Was this helpful?<\/span>\n        <button\n                class=\"was-this-helpful__button fl-text-sm\"\n                aria-label=\"Yes\"\n                value=\"yes\"\n        >\n            <span class=\"was-this-helpful__button-text fl-text-bold\">Yes<\/span>\n            <i class=\"was-this-helpful__button-icon\">\n                <svg width=\"22\" height=\"22\" viewBox=\"0 0 22 22\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                    <g id=\"thumbs-up\" 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20.6839 11.2044 21 12 21L16 12V0.999995H4.72003C4.2377 0.994543 3.76965 1.16359 3.40212 1.47599C3.0346 1.78839 2.79235 2.22309 2.72003 2.7L1.34003 11.7C1.29652 11.9866 1.31586 12.2793 1.39669 12.5577C1.47753 12.8362 1.61793 13.0937 1.80817 13.3125C1.99842 13.5313 2.23395 13.7061 2.49846 13.8248C2.76297 13.9435 3.05012 14.0033 3.34003 14H9.00003Z\"\n                              stroke=\"#666666\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/>\n                    <\/g>\n                    <defs>\n                        <clipPath id=\"clip0_604_3423\">\n                            <rect width=\"22\" height=\"22\" fill=\"white\"\/>\n                        <\/clipPath>\n                    <\/defs>\n                <\/svg>\n            <\/i>\n        <\/button>\n    <\/div>\n    <span class=\"was-this-helpful__taken-action fl-text-sm-bold\"><\/span>\n    <div class=\"was-this-helpful__feedback-container\">\n        <div 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class=\"fl-editors-summary\" data-testid=\"fl-editors-summary\">\n    \n    <div class=\"fl-editors-summary-content\" data-testid=\"fl-editors-summary-content\">\n                    <h2>Can I Solve This on My Own or Do I Need an Attorney?<\/h2>\n                <div class=\"fl-editors-summary-content-main\" data-testid=\"fl-editors-summary-content-main\">\n            \n        <\/div>\n        <ul class=\"fl-list-style-none\">\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    A lawyer can help seek fair compensation on your behalf\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    Drug manufacturers have teams of lawyers on their side to defend against lawsuits\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    An attorney can help gather medical evidence to support your claim\n\n                <\/li>\n                    <\/ul>\n                    <div class=\"fl-editors-summary-content-description\" data-testid=\"fl-editors-summary-content-description\">\n                <p>An experienced attorney can increase your chances of success with your case. Many attorneys offer free consultations.<\/p>\n\n            <\/div>\n                            <div class=\"fl-editors-summary-content-link fl-flex\" data-testid=\"fl-editors-summary-content-link\">\n                <i class=\"fa fa-angle-right medium\" aria-hidden=\"true\"><\/i>\n                <p class=\"find-attorney\"><a href=\"https:\/\/lawyers.findlaw.com\/personal-injury-plaintiff\/#USER_GEO\/?fli=esum:FL3905\" target=\"_blank\" rel=\"noopener\">Find a local attorney<\/a><\/p>\n\n            <\/div>\n            <\/div>\n<\/div>\n\n\n\n<div class=\"email-subscription fl-mb30\">\n    <div class=\"email-subscription-header\">\n        <div class=\"email-subscription-header-content\">\n            <h3 class=\"fl-callout-sm fl-no-margin\">Stay Up-to-Date With How the Law Affects Your Life<\/h3>\n        <\/div>\n        <div class=\"email-subscription-header-image fl-flex fl-items-end\">\n            <img decoding=\"async\"\n                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