Boehringer Ingelheim, the makers of Pradaxa, have recently reached a $650 million settlement regarding the prescription blood-thinning medication. Over the years, thousands of lawsuits have been brought against the German company by defective drug attorneys. The settlement will resolve most of the cases filed by patients and their family members, alleging injuries and deaths incurred as a result of taking the drug.
Pradaxa is used by patients who suffer from atrial fibrillation (irregular heartbeat). The drug is a blood thinner that helps diminish the risk for blood clots and stroke. Approximately 4,000 patients who took Pradaxa allege the company did not properly warn them that the anticoagulant could cause serious, sometimes fatal, bleeding that could not be reversed, as well as other adverse side effects. More than 1,000 deaths have also been linked to Pradaxa, according to the Institute for Safe Medication Practices, an agency that tracks drug safety.
Pradaxa was approved in 2010 and was touted as a safe and effective blood thinner. The drug was hailed because unlike its competitor, Warfarin, it did not require frequent blood tests or dietary restrictions. However, after being prescribed to about 850,000 patients in the U.S., doctors were finding that many people were having adverse effects from the drug--namely intensive internal bleeding. Also unlike Warfarin, Pradaxa does not currently have an antidote. Right now, the only way to stop internal hemorrhaging is for doctors to immediately administer emergency dialysis, which is not always a viable option.
Just a year later, in 2011, the Food and Drug Administration (FDA) issued a public safety announcement regarding reports of excessive internal bleeding in patients who were taking the drug. Patients also complained about many other serious side effects of the drug, including:
- Cerebral hemorrhaging
- Unusual bruising
- Uncontrollable bleeding
- Frequent nose bleeds
- Vomiting blood
- Discolored urine
- Discolored stool
- Bleeding gums
- Heavy menstrual bleeding
- Coughing up blood or clots
Because of the extreme side effects, including death, over a thousand patients formed a multidistrict litigation (MDL) procedure. In multidistrict litigations, one judge manages the litigation on behalf of all clients in order to expedite the legal process and avoid inconsistent rulings. Although gastrointestinal bleeding complaints are at the heart of the Pradaxa MDL case, a real issue is the notion that Boehringer Ingelheim failed to provide sufficient warning to patients and doctors about the risk of serious bleeding.
The lawsuit also claims the manufacturer rushed Pradaxa through mandatory clinical trials (performing just one) in order to speed up the approval process, which would allow the drug maker to be the first one to market, giving it an advantage over its competitors. Plaintiffs also claim Boehringer Ingelheim’s negligent rush to market resulted in a very dangerous drug being used by millions of unsuspecting patients, causing thousands of preventable injuries and deaths.
As a result of the lawsuit, Boehringer Ingelheim announced they will pay $650 million to settle all state and federal lawsuits involving the drug Pradaxa. On average, each claimant will receive about $162,500. The settlement comes about six months before the company was scheduled to begin more clinical trials of the drug, and just a few weeks after the FDA reported that it had concluded its own review of the drug and had determined that additional warnings were not necessary.
The defective drug attorneys at Friedman Rodman Frank & Estrada, P.A. have helped countless individuals and families who have lost a loved one or sustained serious injuries due to taking dangerous prescription medications. We have successfully obtained justice for our clients at jury trials, arbitrations and mediation settlements.
If you or a loved one has been negatively affected by taking Pradaxa or any other prescription medication, contact us immediately at 877-448-8585 or online.