Pradaxa Internal Bleeding & Hemorrhages Lawsuits

If you are among the hundreds of thousands of patients prescribed the revolutionary new blood thinner medication Pradaxa (dabigatran) you may be among those affected by disturbing reports of serious health problems that in some cases have proven fatal. Many Pradaxa users who take the medication to prevent strokes are reporting serious negative side effects such as severe internal bleeding, kidney problems and brain hemorrhages.

Victims who are suffering from these problems and those who have lost loved ones are responding by filing lawsuits in which they are seeking damages from the drug’s maker, Boehringer Ingelheim. If you are among those who have been affected you will want the latest information about this health problem and a full understanding of your legal rights. Our lawyers and attorneys are here to help you with a Pradaxa lawsuit – including a free consultation about your legal options – and offer you aggressive, experienced representation for your suffering.

If you’ve suffered health problems from your use of Pradaxa and would like to add your comments or stories about problems with the medications please see the bottom of this page.

MANY PRADAXA PATIENTS ARE ASKING:
• How do I file a claim or lawsuit over Pradaxa?
• Am I eligible to file a claim or lawsuit?
• How many other Pradaxa lawsuits have been filed?
• I am no longer taking Pradaxa, am I still eligible?
• Besides my medical costs what other damages am I eligible for?
• Do most Pradaxa cases settle or go to trial?
• Is there a time limit for a Pradaxa case to be filed?

PRADAXA PROBLEMS NOT LIMITED TO INTERNAL BLEEDING.

While most of the reports of health problems stemming from the use of Pradaxa deal with internal bleeding there are other issues that have arisen in connection with the use of the drug. CBS News reported on a study that showed that patients taking Pradaxa are three times more likely to suffer a “heart attack or severe symptoms of heart disease” than do patients taking other clotting drugs or placebos. Safety warnings about the drug’s dangers have been posted by health officials in Japan, Australia and by the U.S. Food and Drug Administration. The FDA also has warned that the drug breaks down quickly when removed from its original container, a circumstance which can seriously decrease its effectiveness.

Pradaxa was approved by the FDA and first put on the marketplace in late 2010. It was marketed as a new-wave blood thinner that had superior qualities in protecting victims of atrial fibrillation from suffering strokes. It didn’t take long for problems to surface that called into question the safety of the drug and the testing methods used to ensure that it was appropriately researched in clinical trials. Numerous media accounts and the FDA’s own records show that the agency received over 300 reports of internal bleeding or other serious side effects from the use of the drug during the first three months that it was sold. Also cited was a report detailing Pradaxa adverse events reports listed by the FDA that showed that there were more problems reported with the blood thinner than nearly 99 percent of the other drugs monitored by the federal agency.

WHAT ARE THE ALLEGATIONS IN PRADAXA LAWSUITS?

When you read the details that are contained in drug-defect lawsuits it is impossible not to be heartbroken by the suffering of these victims. Their allegations detail the pain and physical and emotional stress that they and their loved ones have undergone. In some cases families have been financially devastated by the loss of income of the family provider or overwhelmed by financial ruin due to medical costs. The loss of any family member is devastating but even more so when the victim was taking prescribed medication that he or she believed was safe and had undergone regulatory inspection.

Our experienced Pradaxa lawyers have aggressively and successfully pursued many drug-defect cases on behalf of victims. Our legal team has the capability to exhaustively research the records and results involved with the development and approval of medications. Many of the details of these clinical trials and insider information are not public record but they are subject to the requests of our lawyers on behalf of you. Many of the allegations involved in Pradaxa lawsuits deal with whether drugmaker Boehringer Ingelheim Pharmaceuticals Inc. properly researched the effects of Pradaxa and ensured that it would be safe for consumers. There is also the question of whether, in the face of such a large number of reports of problems, that the company became aware of defects in the drug but failed to notify consumers and government regulators as required by law.

The history of drug-defect litigation such as may be involved with the Pradaxa lawsuits is that because they involve similar allegations against a common defendant the massive numbers of such cases may require that they be consolidated into what is called a multi-district litigation. That means that cases from all across the country are brought before a federal judge who oversees evidence-gathering and pre-trial legal activities. It is not uncommon for these cases to be designated as class-action lawsuits in which multi-million dollar settlements are reached on behalf of the victims. Are you eligible? Contact us as soon as possible for a free legal consultation about your case.

WHAT ARE THE SYMPTOMS OF PRADAXA INTERNAL BLEEDING?

These are some of the most common symptoms that have been identified in connection with excessive bleeding by Pradaxa victims:
• Severe headaches
• Repeated nosebleeds
• Constant fatigue
• Weakening or swelling in the body’s joints, arms, hands, legs, ankles or feet
• Feeling dizzy
• Unusual bruises or bleeding, particularly in the gums
• Vomiting blood that looks like coffee grounds
• Coughing up blood
• Menstrual or vaginal bleeding that is heavier than normal
• Unusual colored urine, such as brown or pink
• Unusual colored stools, such as black or red that look like tar
• Coughing up blood

What is Pradaxa?

In the dense prose of medical dictionaries, Pradaxa is a direct thrombin inhibitor designed to block the blood enzyme responsible for causing clots. As the drug’s maker describes it: “PRADAXA is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. PRADAXA lowers the chance of blood clots forming your body.”

All anticoagulants carry some degree of risk of internal bleeding and Pradaxa carries, as required by the FDA, a warning label that informs patients about the possibility of internal bleeding and other side effects.

These side effects are also detailed on the drug’s web site but there is no mention of the high level of concern voiced by the FDA, the large number of reports that have been filed with the agency or the increasing number of lawsuits against the drug’s manufacturer. Drugs such as warfarin, that preceded Pradaxa as blood thinners, also list internal bleeding as side effects but there are antidotes to internal bleeding with those drugs. However, no antidote is available for internal hemorrhaging caused by Pradaxa, which was marketed as an improvement over warfarin because, according to advertising, it is easier to use and requires less monitoring.

In a Dec. 7, 2011 safety communication, the FDA said it is reviewing the reports that it has received of severe bleeding events in people taking Pradaxa: “FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.”

FACTS ABOUT PRADAXA ISSUED BY THE FOOD AND DRUG ADMINISTRATION

• A blood thinner (anticoagulant) known as a direct thrombin inhibitor.
• Approved to reduce the risk of stroke and blood clots (systemic embolism) in patients with non-valvular atrial fibrillation.
• Available as 75 mg and 150 mg oral capsules.
• From approval in October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed.
• Approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies.

Source: U.S. Food and Drug Administration.