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US Judicial Panel on Multidistrict Litigation to Decide on Pradaxa MDL
The U.S. Judicial Panel on Multidistrict Litigation will decide whether to consolidate Pradaxa liability cases in one central federal court on July 26th.
On May 30th, a motion was filed to consolidate all Pradaxa Product Liability cases in one central federal court. This motion follows numerous cases being filed against Boehringer Ingelheim, the manufacturer of Pradaxa. Lawyers expect as many as 500 cases to be filed against the manufacturer.
Plaintiffs are alleging the Pradaxa has led to serious bleeding and even death. Pradaxa actually leads all drugs in the US in the number of adverse drug reactions that patients suffer after taking these drugs.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Pradaxa Leads Adverse Drug Reactions
In 2011, the Food and Drug Administration received nearly 180,000 reports of serious drug reactions – nearly a 10% increase over 2010. Manufacturers are required to report serious events within 15days of receiving a report on a serious event.
Pradaxa, a blood thinner intended to prevent strokes in patients with atrial fibrillation but has been linked to irreversible serious bleeding, received the highest number of reports with 3,781 reports and over 500 deaths.
With some studies showing that only 1% of adverse events are reported to the FDA, the Philadelphia Inquirer estimates that Americans suffered up to 18 million serious reactions from pharmaceutical drugs last year.
Thompson & Tredennick partner Ted Tredennick comments, “Frankly, it’s a little scary that so many adverse reactions occurred last year. I think the lesson here is that the public needs to be better educated and wary of the pharmaceutical industry which is really more interested in satisfying their shareholders than the general public. We’ve seen this time and time again. And if you can get by without taking a particular drug – whether over-the-counter or prescription – by all means do so. Everything has a side effect. Some you can live with and some you can’t. Pradaxa, for example, is one you can’t!“
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Pradaxa and Death from Serious Bleeding
Pradaxa was originally marketed as a more effective remedy for atrial fibrillation, a heart condition that increases the risk of a stroke. Yet, less than two years after its approval in the US, trial attorney Mikal Watts calls it, “the worst drug I have seen” which leads to the “serial killing of Americans that are on this bad drug.”
After being introduced to the public as a rat poison in 1948, Warfarin (Coumadin), the other major medication for atrial fibrillation, was approved in 1954 for use in patients the United States. Since Warfarin interacts negatively with many other drugs, doctors had been hoping for an alternative medication for patients with atrial fibrillation. Pradaxa was marketed as the solution for which doctors were waiting.
However, after 260 deaths due to fatal bleeding related to Pradaxa, it has become clear that Pradaxa is not the solution doctors were awaiting. Instead, there is no reversal agent to stop bleeding that is caused by Pradaxa. As Dr. Bryant Cotton, a Houston trauma surgeon who conducted a study on the risk of Pradaxa, put it, “It’s irreversible — that’s a great idea; a drug that makes you bleed to death and there’s no reversal agent… When prescribing a drug with side effects that include life-threatening hemorrhage, reversal is not ‘desirable,’ it is essential.”
The Houston Press ran an article on May 23rd which discusses Lorain Franklin, a woman from Georgetown, Texas who died as a result of this irreversible bleeding that was caused by Pradaxa. After reading of Ms. Franklin’s story, Thompson and Tredennick Partner Ted Tredennick comments, “”It’s tragic what happened to Lorain Franklin and avoidable. The public needs to know about this and I will shout it from the rooftops if I have to.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Risks of Pradaxa are Underestimated
Doctors from New Zealand are concerned that people are not aware of the risks of the drug Pradaxa.
Pradaxa (Dabigatran) was approved by the FDA in October 2010 as a blood thinner to prevent strokes in patients with atrial fibrillation. Over 86,000 people were prescribed Pradaxa by December 2010.
The manufacturer of Pradaxa marketed the drug as a safer alternative to warfarin. However the medical community has become concerned about the risk of serious bleeding associated with Pradaxa. Three doctors wrote a letter to the editor of the New England Journal of Medicine discussing their study finding that patients who were prescribed Pradaxa had a higher risk of serious bleeding possibly leading to the death of at least one patient under their care. The authors concluded “We are concerned that the potential risks of this medication are not generally appreciated.”
Thompson and Tredennick partner Ted Tredennick comments, “While the people taking Pradaxa generally tend to be older, the drug is dangerous to anyone and everyone. The science appears to be very clear: your chance of suffering a stroke goes up a lot if you are taking Pradaxa. Be careful.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
