Have You or Someone You Love Been Injured by Pradaxa®?
The lawyers at The Roberts Law Firm, P.C. Can Help
Because of the alleged acts and failure to act by large drug companies that manufacture Pradaxa®, people who have experienced side effects were unaware that these increased risks existed. The Roberts Law Firm pursues compensation for your injury or the injury of a loved one. We evaluate claims on behalf of those who were prescribed Pradaxa® and who may have suffered injury.
What is Pradaxa®?
Pradaxa, also known by the generic name of dabigatran, is a prescription medication which was approved in 2010 by the United States Food and Drug Administration (FDA). It was created by Boehringer Ingelheim Pharmaceuticals Inc. and is designed to reduce the risk of stroke and development of blood clots in patients diagnosed with atrial fibrillation. Pradaxa is classified as a direct thrombin inhibitor which works by inhibiting the effects of thrombin, which is a protein in the blood responsible for the clotting. Blocking the ability of thrombin to clot blood decreases the possible formation of a serious blood clot.
Why is Pradaxa® Prescribed?
Pradaxa is a drug that is prescribed to prevent strokes and atrial fibrillation, a condition associated with an irregular heartbeat. When a patient has atrial fibrillation, his or her heart does not beat in a normal rhythm. This can lead to blood clots forming around the heart and traveling to other areas of the body which can lead to stroke. Patients who already have atrial fibrillation are at an increased risk for stroke due to the formation of blood clots that may reach the brain.
Dangerous Side Effects of Pradaxa®
Pradaxa has been marketed as being safer than traditional blood thinners, like Warfarin (brand names Coumadin, Jantoven and Marfarin). The manufacturer claims that Pradaxa will not react with certain foods the way Warfarin will to increase the likelihood of bleeding events. However, Warfarin bleeding can sometimes be stopped with the administration of vitamin K. There is currently no completely effective antidote for Pradaxa bleeding at this time, making Pradaxa bleeding events potentially far more dangerous. Pradaxa has both serious and less severe side effects. Some of the side effects associated with Pradaxa include the following:
- Internal bleeding
- Cerebral hemorrhaging
- Unusual bruising or bleeding / hemorrhaging
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomiting that resembles blood or looks like coffee grounds
- Bleeding from the gums
- Frequent nosebleeds
- Joint pain or swelling
- Weakness and swelling of the arms, hands, feet, ankles or lower legs.
Aside from internal bleeding and gastrointestinal problems, other side effects associated with Pradaxa include myocardial infarction, bruising easily, allergic reactions severe enough to require hospitalization, anaphylactic reaction and shock, increased bilirubin levels and dysfunction of the liver.
Since early after its release, there have been reports regarding the potentially dangerous side effects of Pradaxa. Critics say that Pradaxa was rushed to market before thorough testing of side effects could be completed. In clinical trials it was discovered that approximately 16% of Pradaxa users experienced internal bleeding and approximately one-third of users experienced issues such as severe abdominal pain, digestive tract ulcers, problems with stools, indigestion, reflux disease and other issues. Pradaxa is now sold containing a warning label cautioning users about excessive bleeding that may lead to serious or possible fatal outcomes. Users above age 75, users that suffer from kidney problems, and users suffering from ulcers or intestinal bleeding are at an increased chance of developing excessive bleeding.
Following the release of Pradaxa, Japan’s health ministry reported that 81 elderly patients taking Pradaxa suffered heavy bleeding / hemorrhaging leading to five deaths between March 14, 2011 and August 11, 2011. Japanese officials suggested that patients older than 70 may need a lower dose of Pradaxa. As a result, regulators in Japan asked Boehringer Ingelheim, the maker of Pradaxa, to notify doctors about potentially deadly bleeding and hemorrhaging in some Pradaxa patients.
Shortly after the Japanese reports, in September 2011, Pradaxa became the subject of an investigation in New Zealand. There were reports that as many as five elderly Pradaxa patients reportedly died as a result of internal bleeding and hemorrhaging. An additional 36 patients reported bouts of serious internal bleeding and hemorrhaging.
Finally, on December 7, 2011 the United States’ Federal Drug Administration issued an early warning notification evaluating the postmarketing reports of serious bleeding events in patients taking Padaxa.
Current State of Litigation
Pradaxa is still the most commonly cited drug in adverse event reports submitted to the FDA, according to a new safety report compiled by the Institute for Safe Medicine Practices (ISMP).
In 2012 alone, the FDA received no less than 3,292 complaints concerning Pradaxa side effects including internal hemorrhaging. Deaths arising from Pradaxa were reported in 582 cases.
As of October 2013, 1,591 Pradaxa lawsuits have been filed and many more are expected to be filed in the next several months. The lawsuits for Pradaxa will proceed as a special procedure known as Multidistrict Litigation (MDL). Cases from around the country are transferred to a single court.
One Judge will manage the litigation during the pretrial and discovery process, which may include questioning witnesses, retrieving documents and statements from the parties involved. The Pradaxa MDL is in U.S. District Court for the Southern District of Illinois.
The person presiding over the MDL is U.S. District Court Judge David Herndon. Herndon told the Madison- St. Clair Record that “steady progress” is being made in the Pradaxa MDL. Depositions of officials from the Defendant are scheduled to begin after attorneys from both sides finish producing “tens of thousands” of documents in the discovery phase.
The first trials are now expected to begin in March 2014. These trials are expected to continue through 2015 and beyond, depending on the number of cases in the MDL. Herndon added, “We’re really starting now to get to the meat of the litigation. The pace is picking up.”
How the Roberts Law Firm Can Help You
We believe that if you or someone you love have suffered from a side effect or been injured by Pradaxa® you should be fairly compensated for your damages. Men, women, children and their families have had life-changing experiences as a result of these injuries. Damages can include:
- Medical Bills
- Permanent Injuries
- Emotional Suffering
- Loss in the Quality of Life
- Potential Risk of Future Medical Complications
- Increased Health Insurance Costs
- Lost Wages
Due to both the alleged acts and failure to act on the part of the large drug companies that manufacture Pradaxa® many people who have suffered side effects were unaware that these increased risks existed. The Roberts Law Firm would like to assist you in pursuing compensation for your injury or the injury of a loved one. We are currently evaluating claims on behalf of those who were prescribed Pradaxa® and who may have suffered injury. We are representing injured parties on a contingent fee basis which means that there are no legal fees owed unless you are awarded compensation for your injury. For a free, no obligation case review please call 866-585-4570 toll free or fill out our online contact form and we will contact you to answer any of your questions. If you or a loved one has been injured after using Pradaxa®, The Roberts Law Firm may be able to help.
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The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. We invite you to contact us and welcome your calls, letters and electronic mail. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established.
Your specific situation will depend on the facts specific to your situation many of which cannot be known simply by reading this website. You should clearly understand that the information provided in this website is generalized and may vary greatly depending on the specific nature of your factual issues. The material on this website is not intended to be legal advice but as information.
The Roberts Law Firm, P.C. does not intend, by this web site or otherwise, to provide medical advice to or dissuade anyone from taking medication without their doctors’ approval. Please consult your doctor on matters relating to your health. It could be dangerous to stop taking medicines, especially abruptly. Patients should talk to their physicians to decide whether the benefits and risks of taking Pradaxa® make it the right choice for them.