Nationwide Dangerous Drug Lawyers On Your Side
Pradaxa is a blood thinner introduced by Boehringer Ingelheim in October 2010. The drug was an instant hit, quickly gaining blockbuster status with over $1 billion in sales. By December 2010, however, over 300 patients had reported severe bleeding complications with Pradaxa, with many cases resulting in wrongful death.
These claims closely resemble those filed against Xarelto, another dangerous blood thinner for which we are currently representing clients.
Our team of Pradaxa attorneys has seen first-hand how dangerous this drug is, causing fatal bleed-outs in otherwise healthy patients across the country. We are prepared to fight back against Boehringer Ingelheim. We have been advocating for the injured since 1985 and have a history of success against Big Pharma. Partnering with top litigation firms nationwide, we give our clients a powerful voice. We are available 24/ 7 and can travel to you.
If you or a loved one have been injured by Pradaxa, let us represent your interests and fight for just compensation! Call (800) 794-0444.
Problems with Pradaxa
The drug is prescribed to patients with atrial fibrillation (irregular heartbeat) to prevent blood clots that could cause strokes. It was intended to replace warfarin, the original blood thinner that’s been used for over 60 years. All blood thinners can cause severe bleeding, but unlike warfarin, there is no way to reverse bleeding in patients taking Pradaxa. Praxada works by inhibiting the blood’s ability to clot, so if a patient suffers any type of minor bleed while on the medication, their bodies may be unable to stop bleeding on their own, creating a sort of hemophilia.
Many Pradaxa patients suffered fatal bleed-outs while hospitalized as doctors watched helplessly. Warfarin is easily reversed by vitamin K; no such antidote exists for Pradaxa.
Pradaxa v. Warfarin
Warfarin is extremely effective at preventing strokes, but patients must follow a strict diet and regular doctors’ visits because each patient needs a unique dose. Pradaxa is one-size-fits-all and does not require extensive monitoring, which appealed to doctors and patients alike.
To market Pradaxa, the manufacturer reported it was just as effective as warfarin based on a study called the RE-LY Trial. The legitimacy of that study is widely criticized by medical experts.
Take a look at some of the study’s flaws:
- 18 of the 20 RE-LY Trial authors they were being paid by Boehringer Ingelheim throughout the process.
- Researchers were not “blinded.” Clinical trials must be conducted on a “double-blind” basis, meaning neither the patients nor researchers know who is receiving the experimental drug. RE-LY researchers knew which patients were taking Pradaxa, and, according to FDA reviewers, handled those patients differently.
- The total number of serious side effects was not reported in the study.
- The FDA allowed Boehringer to finalize the scoring system after the experiment was complete.
The reports are so consistent that in 2012 the FDA announced its plans to reassess the drug and its approval. Just one year after Pradaxa’s release, the FDA issued a safety review of serious bleeding events associated with the drug. The agency affirms that in large studies, the risk of major bleeding events for Pradaxa and warfarin are incredibly similar (Boehringer originally claimed Pradaxa was 35% more effective than its rivals). As stated, however, such bleeding events are easily reversed in warfarin patients, and nearly impossible in Pradaxa patients.
Recent reports show risks of Pradaxa are higher than Boehringer initially stated. Pradaxa is linked to more complications and deaths than any other blood thinner, with tens of thousands of patients suffering.
Black Box Warning
In April 2013, three updates were added to Pradaxa’s labels, including the increased risk of stroke in patients discontinuing the medication. Black box alerts are the strongest warnings the FDA can make for a medication.
In essence, the FDA informed patients that this drug, which is intended to reduce the already-small risk of stroke, will in exchange create a new set of dangerous complications that could ultimately lead to premature death.
Pradaxa is under scrutiny by the rest of the world as well. Australia firmly refuses to allow Pradaxa onto its health market, citing the need for further data on the drug’s safety. The Australian government is aware of Pradaxa litigation in the U.S.; in 2014, Boehringer agreed to settle thousands of Pradaxa bleeding lawsuits, and more continue to be filed today.
In 2013, Pradaxa lawsuits were consolidated into multidistrict litigation (MDL) in Southern District of Illinois. An MDL assigns all pending Pradaxa cases throughout the country to one judicial panel. In 2014, days before the first cases were set to go to trial, Pradaxa’s manufacturer, Boehringer Ingelheim announced that it would pay $650 million to settle more than 4,000 injury claims. That averaged to about $162,000 per claimant.
There is currently a possibility for a second wave of litigation against Boehringer Ingelheim. Though they settled a substantial amount, their profits on Pradaxa far outweigh the losses from the settlements. In 2012 alone, Pradaxa sales hit $1.2 billion.
Contact a Dangerous Drug Lawyer - We Can Travel To You
Our dangerous drug attorneys have decades of experience fighting companies like Boehringer Ingelheim and have won millions for our injured clients. Pradaxa litigation is rapidly progressing, so contact our firm today for a free case review to determine if you can take part. We accept clients nationwide and can answer any questions you have about bleeding incidents related to Pradaxa or the legal process.
Don’t hesitate to contact us. Call (800) 794-0444 to speak with a dangerous drug attorney in Illinois.
- New Blood Thinners’ Benefits Doubted
- FDA Reassesses Pradaxa Among Safety Concerns
- New Evidence Further Discredits Pradaxa
- University of British Columbia’s Therapeutics Initiative report “Why we cannot rely on RE-LY”
- New York Times article on $650 Million Pradaxa Settlement
- Institute for Safe Medication Practices Report on Pradaxa bleeding monitoring