Category Archives: Pharmaceutical/Drug Litigation

New Research Points to Risks of Pradaxa Brain Hemorrhage

Ava Lawson | May 15th, 2013 | Posted in Pradaxa Lawsuits


Pradaxa bleeding injuries

Emerging research underscores the potentially fatal consequences of Pradaxa bleeding complications.

The blockbuster anticoagulant was launched by drug maker Boehringer Ingelheim back in October 2010, but the lack of a Pradaxa reversal agent has resulted in hundreds of deaths among recipients, as doctors have few means to stop the effects of uncontrolled bleeding brought on by the medication. This month, two new studies highlight the dangers of intracranial Pradaxa brain hemorrhage among patients who suffered closed head injuries. The research was published in two respected medical journals: Neurosurgical Focus and the Journal of Neurosurgery.

Dr. Brian Walcott, who co-authored one of the studies said, “[Pradaxa] has the potential to provide an important health benefit when used for the proper indications… The lack of an available reversal agent should be recognized as an important current limitation of its use, particularly in patients at a high risk for falls.”

Study reveals dangers of Pradaxa brain hemorrhage

In the Journal of Neurosurgery report, researchers compared case studies among head trauma patients who were on the older blood-thinning medication known as warfarin with patients who took Pradaxa (dabigatran) and others who took no anticoagulants. The study included 15 patients who suffered closed head injuries. Those who were taking warfarin recovered, but of the five patients who were on Pradaxa, two of them died due to brain hemorrhaging that physicians were unable to control, due to the lack of reversal agent. Bleeding events associated with warfarin, on the other hand, can be staunched with a dose of Vitamin K. The team of researchers concluded that “The development of reversal agents is urgently needed given the growing number of patients treated with this medication.”

Pradaxa bleeding complications in patients have led to uncontrollable gastrointestinal (GI) hemorrhages and strokes, prompting scores of lawsuits around the nation. Plaintiffs and the families of those who died from Pradaxa-related bleeding injuries, claim that manufacturer Boehringer Ingelheim failed to properly test the medication before marketing it, and failed to warn consumers about potential risks. The Food and Drug Administration (FDA) has been flooded with adverse event reports involving Pradaxa bleeding events.

In the first quarter of 2011, the agency reported that some 120 people died on Pradaxa and 500 or more patients suffered complications with incidents of Pradaxa hemorrhage or bleeds. These figures are a stark contrast to those associated with warfarin – a drug that requires patients to undertake more frequent monitoring, but has fewer risks of excessive bleeding.

The other study reported in Neurosurgical Focus examined methods and potential reversal agents that could be used to prevent Pradaxa blood thinning effects. Researchers discovered that the only viable means to mitigate these effects was to administer dialysis on patients to cleanse the blood and remove all traces of the drug from the system.

Pradaxa bleeding complications spark wrongful death claims

Though still widely prescribed for patients with atrial fibrillation, adverse Pradaxa side effects have prompted a wave of litigation among individuals who suffered life-altering injuries and complications from the blood-thinning medication. Plaintiffs allege that Boehringer failed to sufficiently alert them about the risks of complications such as Pradaxa brain hemorrhage.

To coordinate pre-trial proceedings, all federal cases alleging Pradaxa bleeding injuries were centralized in U.S. District Court for the Southern District of Illinois, where Boehringer Ingelheim faces hundreds of claims. Judge David Herndon is overseeing the MDL and has scheduled the first trial dates for August 2014. However, both parties will be meeting this August to begin discussions for possible Pradaxa lawsuit settlements.

If you or a loved one have taken Yaz you need to read this.

Yaz and Yasmin both use a new type of progestin hormone called drospirenone, which was designed to reduce many of the side effects of earlier birth control pills. However, researchers have now discovered that this chemical may contribute to more serious health risks.

In early FDA clinical trials, Yaz research identified risks with drospirenone, finding that the hormone could increase the level of potassium in the blood, leading to heart attacks and blood clots.

In August of 2009, The British Medical Journal published two independent studies conducted in Denmark and The Netherlands. Both found that women taking drugs like Yaz and Yasmin, with the hormone drospirenone, had higher risks for blood clots.

The British Medical Journal published further Yaz research in October of 2011 with a study from the University of Copenhagen finding that drugs like Yaz could increase the risk of venous blood clots.


FDA Blood Clots Risk Study

On October 27, 2011, the FDA released its own study of more than 800,000 women. Although it reached similar results, the FDA study quantified that drugs like Yaz containing drospirenone could actually increase the risk of blood clots by as much as 74%.

With such high occurrence rates and estimates that more than 80 million women have taken these birth control drugs, it came as little surprise when The Institute for Safe Medicine Practices reported that Yaz and Yasmin ranked second highest in 2011 for the number of complications reported to the FDA.

With Yaz research mounting and more than 10,000 lawsuits filed by women alleging serious side effects, Bayer announced in early 2012 that it would begin settling injury claims. The company has reserved more than $1 billion to settle these claims and continues to resolve cases for those affected.

Granuflo and Naturalyte claims information, FDA Issues advisement

The FDA has advised health care professionals and patients that GranuFlo and NaturaLyte products when inappropriately prescribed or administered in dosing errors may cause life-threatening cardiac problems. “This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest,” the FDA said in its announcement. “This product may cause serious adverse health consequences, including death.”

If you have been treated with these drugs, please contact Rebecca or Shane Langston at Langston and Langston PLLC. 1 (888) 329-0827,,

(Reuters) INSIGHT-Top heart doctors fret over new blood thinners

By Ransdell Pierson

(Reuters) – For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.

But growing complaints of risks and deaths tied to the new crop of drugs have made some t op U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used.

Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s.

“The good news is you now have an alternative to warfarin,” said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California. “The bad news is you can kill a patient as easily with the new drug as you could with the old drug” if it is not handled properly.

“The average patient doesn’t understand anything about the new drug, or what the risks are, or what other medicines he can or can’t take,” said Jacobson, citing interactions with common painkillers and other drugs that can alter Pradaxa blood levels.