Below are answers to some frequently asked questions about Pradaxa lawsuits, including:
- Who can file a Pradaxa lawsuit?
- Is there a Pradaxa class action?
- What should I do if I am still taking Pradaxa?
- Which Pradaxa lawyers run this website?
- Is Pradaxa better than Coumadin?
This post also provides some background on the latest news about Pradaxa, and how the drug came to be approved by the FDA and still not recalled despite the risk of serious injury or even death. You can also read my post about the initial lawsuits and how there’s still no reversal agent, and my article about a recent study raising doubts over whether Pradaxa is better than Coumadin.
Still looking for more information? Give us a call at 215-948-2718 or use the online form to the right for a no-obligation consultation. We won’t ask you to sign anything just to talk.
Who Can File A Pradaxa Lawsuit?
Pradaxa consumers could allege a number of legal claims including consumer fraud, negligence, strict liability, defective drug design, and defective drug warnings. Our law firm focuses on serious injury and catastrophic cases, and so we have limited our Pradaxa litigation practice to anyone who was hospitalized or died from excessive bleeding (including bleeding in the brain or cerebral hemorrhaging, such as after a fall), kidney failure, or a heart attack while taking Pradaxa.
Is There A Pradaxa Class Action?
There are no certified Pradaxa class actions and, given recent changes in the law limiting class actions, it is unlikely there will be any. The Praxada litigation is in its very earliest stages, and to date only one case has been filed, in March 2012. Our law firm, like many other consumer protection law firms, is accepting cases and preparing them for litigation, with an eye towards ensuring the cases are not dismissed by the courts. Like with class actions, recent changes in the law have made it harder for injured patients to recover compensation from negligent pharmaceutical companies, and so we make sure that our cases are as well prepared as they can be before we file them.
What Should I Do If Am Still Taking Pradaxa?
Talk to your doctor about the new FDA drug safety communication from December 2011, and ask your doctor if you are at risk of kidney issues that might increase the risk of having a Pradaxa overdose.
Also, as mentioned by that FDA drug safety communication, call your healthcare professional and seek immediate care if you develop any signs or symptoms of bleeding such a
- unusual bleeding from the gums
- nose bleeding that happens often
- menstrual or vaginal bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or that get larger
- coughing up blood or blood clots
- vomiting blood or vomit that looks like coffee grounds.
Which Pradaxa Lawyers Run This Website?
Hundreds of law firms are currently advertising for Pradaxa clients with commercials on television, radio, and the internet — but with many of those commercials you can’t tell who is even behind the commercial, much less if the law firm has a history of successfully representing injured people.
I’m not a an actor on a television commercial or someone in a call center: I’m a real lawyer who has successfully tried serious injury and wrongful death cases in front of juries, and I successfully handled prior Pradaxa lawsuits. If you use the contact form below, the email goes to me.
Background On The Undisclosed Pradaxa Side Effects
This section is adapted from my post, Pradaxa Bleeding Lawsuits Begin; Still No Reversal Agent Available.
A recent CDC study confirmed that warfarin, anti-platelet medications, and diabetes control medications together accounted for a whopping two-thirds of all drug-related emergency hospitalizations of senior citizens. Errors in dosing and monitoring warfarin by health care professionals, too, account for a significant (over 1%) of medical malpractice claims.
Warfarin works in treating or preventing the deadly conditions venous thrombosis, blood clots, and pulmonary embolism by almost creating a different deadly condition: excessive bleeding. It doesn’t take much to push a patient into dangerously high prothrombin ratio (INR) levels, and so healthy patients need to have blood tests weekly or at least monthly, and hospitalized patients need to be monitored every few hours. Warfarin is thus both a wonder drug — which has saved the lives of my own family members diagnosed with pulmonary embolism — and a double-edged sword, because it causes major bleeding episodes in 3-5% of people taking it. Scientists have been trying to find safer replacements for the whole fifty years that it’s been used.
Pradaxa (dabigatran etexilate), manufactured by Boehringer Ingelheim Pharmaceuticals, was supposed to be one of those replacements. In September 2009, the initial results of the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study sponsored by the company were released, with the study’s authors — the bulk of whom reporting in the study “receiving consulting fees, lecture fees, and grant support from Boehringer Ingelheim” — concluding:
In conclusion, we compared two doses of dabigatran with warfarin in patients who had atrial fibrillation and who were at risk for stroke. As compared with warfarin, the 110-mg dose of dabigatran was associated with similar rates of stroke and systemic embolism and lower rates of major hemorrhage; the 150-mg dose of dabigatran was associated with lower rates of stroke and systemic embolism but with a similar rate of major hemorrhage.
Note the use of the word “similar” in the study’s conclusion. It’s not a scientific term, it’s a term of art. In fact, when the RE-LY study came out, there was already concern among the FDA advisory panel members that the drug didn’t really offer an improvement over warfarin in preventing stroke in patients with atrial fibrillation, but rather offered just a different balance of the risk of bleeding versus the risk of stroke. In other words, a 110-mg dose was substantially less effective than warfarin in reducing strokes, while the 150-mg reduced strokes but had the same bleeding rates as warfarin.
On the surface, that makes it sound like Pradaxa is an improvement over warfarin, but it’s not the whole story.
If a patient has overdosed on warfarin and starts to bleed, the effects can be quickly reversed with a dose of Vitamin K. If a patient overdoses on Pradaxa and starts bleeding, there’s nothing anyone can do but wait for their kidneys to process the Pradaxa and excrete it in the urine — a process that takes hours at best, potentially long if Pradaxa has slowed kidney function, as many people expect it can.
Based on the RE-LY conclusions, in October 2010 the FDA approved Pradaxa “for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).” The FDA-approved warning label, however, mentioned only “Pradaxa can cause serious and, sometimes, fatal bleeding,” without mentioning the key part: that a Pradaxa overdose, unlike warfarin, can’t be reversed. In the tiny print buried deep in the “full prescribing information,” it mentions that dialysis can be attempted, but admits “data supporting this approach are limited.” If a patient slips into excessive Pradaxa levels — which is a real risk, given that Pradaxa affects kidney function and given that Pradaxa’s primary marketing “hook” to doctors and patients was the claim that INR levels don’t need to be checked as frequently — then there’s no treatment.
It’s even worse given how Pradaxa’s label also admits, again in tiny print buried in the prescribing information, that “risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs),” which a large number of the target patients are taking.
In February 2011, the American College of Cardiology Foundation and American Heart Association added it to the guidelines of non-valvular atrial fibrillation. Sales skyrocketed — and so did adverse drug events. The Institute for Safe Medication Practices reported that, in the first quarter of 2011 alone, “Dabigatran (PRADAXA), a new drug approved to reduce the risk of stroke by inhibiting blood coagulation, generated a strong signal illustrating the substantial bleeding risks of this treatment, with more than 500 reports of fatal, disabling and other severe hemorrhages.”
Reports of internal bleeding, kidney failure, heart attack, and other blood thinning complications including death continued to mount, so that in December 2011 the FDA announced it was evaluating the post-marketing data on Pradaxa, with a warning to doctors to closely monitor renal function — because the problem may be that Pradaxa is clearly quickly enough in patients with below normal renal function — and a warning to patients about reporting any signs of bleeding (e.g., the gums, the nose, coughing, etc) to their doctor.
A month later, in January 2012, Boehringer Ingelheim updated part of the fine print on its label, but not by much. The new label admits that “protamine sulfate and vitamin K” are useless in treating a Pradaxa overdose, then speculates about various ways an overdose can be treated, including the use of various recombinant protein factors, although the label admits “their use has not been evaluated in clinical trials.”
In March 2012, the Journal of Neurosurgery published a case report explaining how neurosurgeons were completely unable to treat “an elderly patient, being treated with dabigatran [Pradaxa] for atrial fibrillation, who presented with a rapidly expanding intracranial hemorrhage after a ground-level fall.” In the course of six hours, the patient’s brain bleed expanded extensively, despite attempting treatments like recombinant factor VII. The authors concluded, “in the event of catastrophic hemorrhage no effective reversal agent exists.” Put simply, if a patient on Pradaxa suffers a serious trauma, doctors are helpless to treat it.
What Do The People Injured By Pradaxa Allege In Their Civil Lawsuits?
Although the complaints will allege multiple theories — strict liability, negligent, negligent design, and consumer fraud — the bulk of drug liability claims these days allege some form of failure to warn. In other words: Pradaxa should warn patients that the drug is more dangerous than warfarin if a patient falls or has an accidental overdose. There’s no question among neurosurgeons and pharmaceutical researchers that, at the moment, Pradaxa has no antidote — and Boehringer Ingelheim has a legal duty to inform patients of that fact.