Pradaxa Mechanical Heart Valve Internal Bleeding Lawsuit

By Top Class Actions | June 22, 2012

Category: Pharmaceuticals

Boehringer Ingelheim Releases Plan to Treat Mechanical Heart Valve Patients with Pradaxa. Lawsuits to follow?

By Scott Hardy

Pradaxa Pill Internal Bleeding Hemorrhage Lawsuit Attorney

More than 300,000 patients every year, worldwide, undergo heart valve surgery and that number is just expected to go up. Each one of those patients will be required to take an anticoagulant or blood thinner for the rest of their lives. Boehringer Ingelheim is going after this large market by attempting to get Pradaxa (dabigatran) approved for use with mechanical heart valve patients.

Boehringer Ingelheim’s desire to enter this market is concerning for many as Pradaxa was connected to more deaths in 2011 than any other legal drug. Pradaxa’s alleged flaw is that it may do its job too well. Pradaxa is in the anticoagulant family of drugs and stops blood from clotting. It’s a common treatment for atrial fibrillation. The issue is that once you have Pradaxa in your system you are at a much greater risk of experiencing uncontrollable internal bleeding or hemorrhage. If you were diagnosed with internal bleeding or hemorrhage after taking or while on Pradaxa, you or a family member should contact a Pradaxa Internal Bleeding law firm immediately.

Currently Coumadin (warfarin) is the most popularly prescribed blood thinner in the world and is the most popular drug prescribed to patients who undergo mechanical heart valve surgery. Coumadin (warfarin) can also have major side effects as it’s been shown to lead to brain hemorrhage or severe internal bleeding just like Pradaxa . The main difference in treating internal bleeding for Pradaxa patients compared to Coumadin patients is that doctors can stop the effects of warfarin relatively easily by flushing the patient’s system with Vitamin K. Vitamin K counteracts the effect of Coumadin (warfarin) and allows the blood to clot regularly which helps stem internal bleeding or hemorrhage. Pradaxa cannot be counteracted as easily as Coumadin (warfarin.) Pradaxa patients must be placed on dialysis so the drug is flushed from at least 60% of their system. This can take 2 – 3 hours and during that time the patient could experiencing massive blood loss which may result in multiple blood transfusions and even death.

Professor Klaus Dugi, Corporate Senior Vice President of Medicine for Boehringer Ingelheim had this to say their quest to get Pradaxa approved for mechanical heart valve patients: “It is vital that patients with mechanical heart valves are provided with anticoagulant therapies that are safe and effective over the long-term. The current treatment… is associated with significant limitations…” Professor Dugi is specifically referring to Coumadin (warfarin) and the patient’s need to change their diet, receive regular blood tests as well as regular monitoring of the patient which some find invasive.

Coumadin will like still lead for years to come, even if Pradaxa is approved, as it only costs about $200 per year compared to Pradaxa which costs about $3,000 per year. The cost, along with the decades warfarin has been available, will have a large impact on the number of physicians who prescribe Pradaxa rather than Coumadin. Physicians will also have to bear in mind the hundreds of Pradaxa internal bleeding lawsuits expected to be filed in 2012.

So far Pradaxa has only had a limited trial on patients with mechanical heart valves and is not approved for this use yet. As stated by Dr. Richard Besdine, the director of the Center for Gerontology at Brown University, “If there’s an adverse event lurking in the closet for a new drug, it’s most likely to come out in patients that are old and frail and taking multiple medications. They’re the canary in the coal mine.” This relates to Pradaxa’s use compared to Coumadin in atrial fibrillation patients but the same logic applies to any new drug that approved to treat new conditions, especially conditions which are most prevalent in elderly patients.

Pradaxa users have filed lawsuits alleging that the anticoagulant drug has severe undisclosed side effects which have killed patients. Pradaxa internal bleeding, wrongful death, or hemorrhage lawsuits typically allege that Boehringer Ingelheim did not adequately inform patients and their prescribing doctors of the risks of uncontrollable internal bleeding and hemorrhage associated with Pradaxa usage, nor did Boehringer Ingelheim warn or otherwise advise on how to intervene and stabilize a Pradaxa patient should a bleed occur after an accident or during surgery. Boehringer Ingelheim has stated that they are working on an antidote or treatment to help doctors when a Pradaxa patient is admitted with hemorrhage or severe internal bleeding.

It’s important that Pradaxa patients know the preliminary signs of internal bleeding. Common internal bleeding symptoms include pink or brown urine, red or black stools, bruises that happen without a known cause and may get larger, coughing up blood or blood clots and/or vomiting blood or vomit which includes particles that look like coffee grounds. If you or a family member are taking, or were taking Pradaxa or Coumadin (warfarin,) and experienced internal bleeding or hemorrhage you may be able to file a lawsuit to help you pay for your medical expenses, pain and suffering, and recovery. Only a qualified Pradaxa hemorrhage or internal bleeding lawsuit lawyer can determine if you have a case. In addition, the spouse of a Pradaxa victim of internal bleeding or hemorrhage may be able to join the lawsuit as a co-plaintiff and sue for “loss of consortium.” You can read the full text of Boehringer Ingelheim’s press release regarding their clinical trial of Pradaxa on mechanical heart valve patients here.

If you would like more information about filing a Pradaxa internal bleeding class action lawsuit, would like to speak with experienced Pradaxa lawyers who are actively filing internal bleeding cases, or would like to file a Pradaxa hemorrhage personal injury lawsuit just go to the Pradaxa Internal Bleeding Class Action Lawsuit Investigation page. Pradaxa attorneys are actively investigating all claims regarding internal bleeding, wrongful death, hemorrhage and other problems which may have been caused by Pradaxa (dabigatran), warfarin (coumadin), blood thinner or other anti-coagulant medications. Remember, the Pradaxa lawyers who work with Top Class Actions will tell you if you have a case for free. There’s never any charge for an initial consultation with an attorney filing Pradaxa lawsuit you find through Top Class Actions. They don’t get paid unless you do.

Updated June 22nd, 2012

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