Wednesday, March 28, 2012

Pradaxa (Dabigatran) Lawsuits

March of 2012 saw the first lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa. This drug was the first of its type to be marketed in over half a century, and Boehringer had high hopes that Pradaxa would knock its only competitor, Warfarin, out of the running in short order. Pradaxa works differently from Warfarin; while both drugs are used to prevent stroke in patients with atrial fibrillation, Warfarin works by inhibiting the production of Vitamin K, a clotting agent in the body. Should there be excessive bleeding in a patient who has taken Warfarin, doses of Vitamin K can be administered to slow the bleeding. Pradaxa, on the other hand, works by inhibiting thrombin, an enzyme in the blood which also controls blood clotting. At this time there is no known antidote to Pradaxa in the event it leads to excessive or uncontrollable bleeding.

What is Atrial Fibrillation?

Atrial fibrillation affects more than two million Americans and is characterized by rapid, uncoordinated contractions in the upper chambers of the heart. Patients with atrial fibrillation are at a much higher risk of developing blood clots, and since the 1950’s doctors have been using Warfarin—which is also known as Coumadin—to help lessen the likelihood of stroke. The FDA approved Pradaxa for use in patients with atrial fibrillation in October of 2010, yet less than a year later reports were coming in regarding serious side effects and even death among Pradaxa users. In December of 2011, in the face of hundreds of adverse reports, the FDA issued a safety warning to patients and physicians, stating they would taking a hard look at the prior Pradaxa studies.

Pradaxa Timeline

Pradaxa was approved in October, 2010, and aggressively marketed as an alternative to Warfarin, yet between the drug’s approval and December of 2010, over 300 adverse event reports were filed with the FDA. Many of these adverse event reports involved serious bleeding, particularly in older patients. This first FDA review also revealed that Pradaxa was being prescribed for off-label use as a general blood thinner. This off-label use was at least in part attributed to Boehringer’s aggressive marketing techniques and failure to provide accurate prescription and warning information. In August of 2011 Japanese officials demanded that Boehringer notify physicians in their country about the potential for excessive or fatal bleeding in patients taking Pradaxa as well as the fact that there is no antidote to reverse bleeding. In November, 2011 Boehringer announced that at least 260 cases of fatal bleeding have been linked to Pradaxa and the next month the FDA announced it would be evaluating the drug further.

Pradaxa Lawsuits

February of 2012 saw a review of Pradaxa published in the Journal of American College Cardiology regarding patients who had experienced adverse bleeding while taking the drug. Hematologists in Australia and New Zealand noted a total of 78 severe bleeds in Pradaxa users in a relatively short amount of time. Then in March the Journal of Neurosurgery published an article detailing an 83-year old Pradaxa user who fell and bumped his head. Although the man appeared to have only a small hemorrhage in the brain, within six hours of the brain scan he fell into a coma and died. The doctors were unable to slow the bleeding and save the man’s life because there is no antidote to Pradaxa.

The first three landmark federal court Pradaxa lawsuits were filed this last week of March in Louisiana, Kentucky and Tennessee. It is likely that Pradaxa lawsuits will focus on Boehringer’s failure to sufficiently warn Pradaxa users about the potential for excessive bleeding or to provide instructions on what to do in the case of an uncontrollable bleed. A Tennessee woman is bringing one of the first three lawsuits on behalf of her elderly mother who suffered an uncontrollable gastrointestinal bleed following the use of Pradaxa. According to court records, after taking Pradaxa for only two months the woman was hospitalized for a gastrointestinal bleed which eventually caused her death.

Possibility of a Class Action Suit

Drug manufacturers are under strict legal obligation to warn consumers of any potential risks their product could present, and when they fail to issue these warnings they may be held accountable. As of this time there is not yet a Pradaxa class action lawsuit, and all complaints are being pursued as individual claims. As more cases come forward it is possible there may be a consolidation or centralization in one court for pretrial proceedings. Although similar to a class action suit each lawsuit remains an individual claim and will be weighed on its own merits.

No Recall--Yet

While the FDA did require a label change for Pradaxa in January of 2012 which added minimal information regarding the potential of the drug to cause excessive bleeding and the current lack of an antidote to this bleeding no black box warning or FDA recall is yet on the horizon. If you or a loved one has taken Pradaxa and suffered grave injury or death, you may have a product liability case against the manufacturer of Pradaxa.

Getting the Help You Need

Because the statute of limitations in product liability cases is relatively short—2 to 6 years depending on the state you reside in—there is a very limited window of time in which you are allowed to file a suit and obtain compensation for your injuries. Pradaxa victims may be entitled to monetary damages for medical expenses, lost wages and certain other damages the court may decide upon.

Author: Sullo & Sullo Attorneys

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