Attorney: Patients Did Not Realize Pradaxa Has No Antidote

Dallas, TXWith thousands of Pradaxa lawsuits alleging patients suffered serious Pradaxa side effects pending, bellwether trials in the litigation have been scheduled and are expected to start in the coming months. Meanwhile, the maker of Pradaxa has been fined by a court for failing to preserve important documents. Dr. Shezad Malik, founder of the Dr. Shezad Malik Law Firm, says Pradaxa was marketed as being better than other drugs, but it came with serious risks.

The issues surrounding Pradaxa are an alleged failure to warn that patients might wind up with serious bleeding problems if they take Pradaxa and a failure to warn that there is no known antidote for Pradaxa if a serious bleeding incident should occur. Pradaxa was introduced on the market in October 2010, to prevent strokes in patients with non-valvular atrial fibrillation.

“Pradaxa was supposed to replace an older, tried and tested drug known as Coumadin [generic name, warfarin], which had been available for 40 years,” Malik says. “Pradaxa was supposed to be superior to Coumadin and have a better side effect profile, but subsequent studies found adverse event reports. Specifically, they found uncontrollable bleeding events.”

Pradaxa and Coumadin are anticoagulant drugs - they prevent strokes by preventing blood from clotting. But in some cases, such as accidental cuts or internal bleeding, failure of the blood to clot can be fatal. Patients taking Pradaxa could suffer life-threatening cerebral hemorrhage or severe gastrointestinal bleeding because there is no antidote. Likewise, a simple cut from household chores could result in uncontrollable bleeding. Minor bumps and scrapes might not be treated with a Band-Aid and pressure because the Pradaxa can stop the blood from clotting.

Worse for some patients, however, is that they may have switched from Coumadin to Pradaxa after being told Pradaxa was a better drug, even though Coumadin has an antidote.

“With Coumadin, the uncontrollable bleeding could be reversed with vitamin K and plasma, but with Pradaxa there is no known antidote,” Malik says. “Pradaxa is a medication that is more expensive than Coumadin with no benefits on the side effect profile but all the risks of uncontrollable bleeding. Many patients would not have switched had they known. Pradaxa was touted by Boehringer Ingelheim as being easier to use because there was no monthly monitoring and no test for blood thinning. But folks didn’t realize that when switching there was no antidote should there be a bleeding incident.”

According to Malik, there are currently more than 2,000 cases pending in the Southern District of Illinois under Judge David Herndon. Those cases have been consolidated for multidistrict litigation, allowing both sides to evaluate the cases. The first bellwether trial, filed by Suzanne Mackiewicz, daughter of Malachy Higgins, has been scheduled for September 2014, with bellwether trials expected to run until March 2015.

Even though the first bellwether trial has been scheduled, it is not too late for people affected by Pradaxa, or their loved ones, to contact an attorney and file a lawsuit. Boehringer Ingelheim has already reportedly faced sanctions for its actions concerning Pradaxa, according to Malik.

“Judge Herndon fined Boehringer Ingelheim almost $1 million for destroying or not preserving key documents to be used in the trial,” Malik says. “Our firm and other mass tort attorneys are still accepting clients. We’re looking at cases where people have died from uncontrollable bleeding while using Pradaxa, or where they have severe bleeding injuries that have been treated. We’re also seeing cases of severe gastrointestinal bleeding, where patients have been in hospital for weeks, had several blood transfusions and days of medical therapy to stop the bleeding.”

In most states, the statute of limitations is two years, although it can run in some states from one year up to six years. Even if patients think the statute of limitations may have run out in their case, it is still a good idea to contact a mass torts attorney.

“Boehringer Ingelheim either knew or should have known that there was no antidote for Pradaxa, but doctors and patients were not warned about that,” Malik says.