Boehringer Ingleheim the manufacturer of Pradaxa (dabigatran etexilate mesylate) is preparing their defense for the upcoming Pradaxa case trials. The manufacturer will likely be battling claims of failure to warn, negligence, wrongful death, improper marketing practices and more. It has been reported that hundreds of people have died from uncontrolled bleeding while using Pradaxa.
Pradaxa Bleeding Deaths: Why Can’t Internal Bleeding be Controlled in Patients on Pradaxa?
Most if not all announcements published by the Food and Drug Administration (FDA) contain in the header of the announcement, the following words “FDA – U.S. Food and Drug Administration: Protecting and Promoting your health”. The FDA, however, must rely on information provided by the specific manufacturer seeking approval for a new drug or medical device. So, on October 19, 2010, the FDA announced their approval of Boehringer Ingleheim’s anti-coagulant (blood thinner) drug Pradaxa, despite the fact there is NO known antidote. By the end of 2011, more than 500 possible Pradaxa deaths had been reported.
Pradaxa Class Action Lawsuit vs Pradaxa Multi-district Litigation (MDL)
On August 8, 2012 the United States Judicial Panel filed the transfer order for the consolidation of Pradaxa litigation into an MDL case number 2385. All parties agreed on the consolidation but disagreed on the location of the MDL. Boehringer most likely was hoping for a location favorable to their cause. In other words, they probably would have preferred a location where they are an employer of a large number of individuals. Ultimately, the Pradaxa case was assigned to Federal court in the Southern District of Illinois and is presided over by Judge David R. Herndon. According to the United States Judicial Panel, Judge Herndon is a “jurist with the willingness and ability to handle this litigation.” Judge Herndon is an experienced MDL judge that “has deftly presided over In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 655 F. Supp. 2d 1343(J.P.M.L.2009), another large pharmaceutical product liability litigation”
Typically, a defective product litigation involving drugs will be consolidated into an MDL rather than a class action lawsuit causing confusion for some. The two are similar in that both involve many cases. The Pradaxa litigation is an MDL. If this were a Pradaxa class action lawsuit, it would be one lawsuit filed by one on behalf of many. That differs in the regard that with an MDL, the cases are consolidated but each individual lawsuit remains a separate and distinct Pradaxa lawsuit.
Who Has Filed Pradaxa Lawsuits?
Many of the lawsuits that have been filed against Boehringer Ingleheim in the Pradaxa case are death cases filed by family of the decedents. Other people have survived their bleeds but have sustained medical bills, possible loss of income, loss of consortium (spousal relations) potential permanent damage as well as pain and suffering. In many cases, filing a lawsuit or a Pradaxa case may be the only way to obtain financial compensation or compensation of medical bills and other related expenses.
What Can Cause Pradaxa Bleeding?
The very nature of a blood thinner increases the risk of bleeding. Clotting is the body’s way of controlling bleeding but in some people, clots can be dangerous. In those cases doctors will prescribe a blood thinner to prevent or slow the formation of a clot. Even in patients where clotting must be controlled, sometimes clotting is not only advantageous, it is necessary. The best case scenario is to be able to prevent clots but if an unwanted bleed begins, to be able to control that bleed. The only known means of controlling a Pradaxa bleed is emergency dialysis and even that must be done within narrow time limits.
Unfortunately, bleeding is often insidiously quiet in the beginning and horrifically frightening in the end. A patient taking Pradaxa may experience a gastric bleed. The cause can be an ulcer or any source of gastric bleeding. Initially, the bleeding is mild so goes unnoticed. Eventually, there may be some discomfort or a distended abdomen. By the time the individual realized they are in trouble or seeks medical intervention, it may be too late.
Emergency room physicians have written articles about the horror of receiving patients, realizing the emergent need to stop or slow the bleed only to find there is nothing they can do. Nothing will reverse the anticoagulant effects of Pradaxa. Death is sometimes the only possible outcome.
Another possible cause of a Pradaxa bleed could be a fall or bump on the head that would under other circumstances be considered a minor incident. Records being produced as the Pradaxa bleeding cases progress indicate some people have sustained minor falls, present at the emergency room with some degree of bleeding in the head. Typically, a patient on blood thinners with internal bleeding would be administered vitamin K, a clotting agent that reverses the effects of Coumadin (Warfarin). If the patient is on Pradaxa, no amount of vitamin K will slow or stop the bleeding. Family members and healthcare providers alike have reported their experiences of watching a patient or loved one literally bleed to death, unable to help.
Has the FDA Recalled Pradaxa?
No, Pradaxa blood thinner has not been recalled. According to the United States Judicial Panel, the factual questions arising from Pradaxa lawsuits include the “potential for severe or fatal bleeding and that there is no reversal agent to counteract the Pradaxa’s anticoagulation effects”. Reportedly, doctors, Pradaxa lawyers and others with expertise in Pradaxa bleeding have raised the question of the potential negligence of Boehringer Ingleheim moving the product to market while aware of the absence of the ability to control bleed.
Who Can File a Pradaxa Lawsuit?
A Pradaxa lawyer can evaluate your case. Only you can make the call that could protect your rights under the law. Only a lawyer can offer legal advice but people that may have a Pradaxa case can include:
- In a Pradaxa death case, family members usually have a right to bring a Pradaxa claim.
- Anyone that suffered a significant bleeding event and was taking Pradaxa at the time can take advantage of a Free Case Evaluation to find out more about a possible Pradaxa lawsuit.
- Individuals that required hospitalization for a Pradaxa internal bleed
- People that sustained significant medical bills following a Pradaxa bleed
- Those that suffered lost income
- Pradaxa patients that may have suffered permanent damage (example – damage from a Pradaxa brain bleed)
How Do I Get a Free Case Evaluation?
- Fill out our contact form found to the right or above
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How Much Will it Cost if I File a Pradaxa Lawsuit?
Pradaxa litigation is taken on a fee contingent basis. This means you are never asked for any up-front money. A Pradaxa attorney is paid from the proceeds of the case. This means if they do not win you do not pay. The Pradaxa lawyer is paid a percentage of the award or settlement. Typically, what experienced Pradaxa lawyers are paid will run about 40% but may be less in some circumstances and in some states. Pradaxa lawsuits are complex. The lawyer you retain must have been admitted to Federal court. He or she should have strong financial resources and experience in not only defective product cases but cases involving large pharmaceutical companies and multi district litigation Your first and foremost consideration should be the quality and experience of the lawyer. Discuss openly the specifics of your fee agreement.
What if I Want to Wait to Talk to a Lawyer or File a Pradaxa Claim?
Time limitations apply and once your time limit for filing has passed, you may lose your right to file. Depending on State and Federal regulations, and in some cases the date of FDA warnings, your time limits may be fairly narrow. You should discuss time limits with a Pradaxa Lawyer.
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