Millions of Americans suffer from a pattern of irregular heartbeats known as atrial fibrillation (AF). In order to reduce the risk of blood clots and stroke, many AF patients rely on anticoagulant medications, more commonly known as blood thinners. Anticoagulants prevent a protein called "thrombin" from forming blood clots. In turn, blood thinners can help reduce the risk of conditions associated with AF, such as heart disease and stroke.
Pradaxa, a brand name version of the generic drug dabigatran, is a popular anticoagulant medication. Recently, reports questioning the safety of Pradaxa have surfaced. Many Pradaxa users have complained of health complications. In extreme cases, these complications have reportedly resulted in death. As a result, a number of patients have filed lawsuits against Pradaxa's manufacturer.
Pradaxa vs. Coumadin
Manufactured by Boehringer Ingelheim, Pradaxa was approved for use by the Food and Drug Administration (FDA) in 2010. After receiving FDA approval, Pradaxa enjoyed immediate success, reaching global sales of $1 billion in 2011 alone. Much of the drug's popularity and sales can be attributed to advertising that portrayed Pradaxa as a better treatment for AF than the traditional Coumadin medication (generic: warfarin). Coumadin can be inconvenient because it requires patients to have weekly checkups and comply with strict dietary restrictions. Pradaxa, on the other hand, eliminated these requirements while retaining similar levels of effectiveness as Coumadin.
The non-profit Institute for Safe Medication Practices (ISMP) found that in 2011, Pradaxa was the medication most commonly linked to complications and deaths. According to FDA data, no other drug had more adverse incidents reported to the FDA. Common side effects associated with Pradaxa include:
- Inflammation in the joints
- Stomach issues
- Coughing blood
Heart attacks, in particular, are a very serious complication associated with Pradaxa. According to a study by the Cleveland clinic, Pradaxa users have a 33% higher risk of developing coronary heart disease or suffering from a heart attack as compared to traditional warfarin users.
Risk of Bleeding
Bleeding is another serious health complication linked to Pradaxa. In fact, bleeding has been a point of focus in much of the current litigation. Many users or their surviving family members have alleged that Pradaxa caused massive internal bleeding, resulting in death in some cases. Pradaxa reportedly has an extreme impact on blood proteins, causing the blood to become very thin and leaving the user susceptible to internal or external bleeding. The ISMP study concluded that 63% of complications with Pradaxa were related to bleeding issues, making it the most common complication linked to the medication.
In November 2012, the FDA released an official statement declaring that Pradaxa does not pose a higher risk of bleeding than its competitor warfarin. However, the FDA also announced that it would closely monitor Pradaxa in addition to conducting its own follow-up studies to assess the chances of bleeding complications. It is possible that in the future the FDA could alter its stance on the safety of the drug.
Many product liability lawsuits have been filed against Boehringer Inghelheim over Pradaxa complications. Under product liability law, manufacturers and sellers have a duty to ensure that their products do not carry any unexpected dangers or defects. Some plaintiffs have accused Boehringer of failing to adequately warn them about the risk of bleeding associated with Pradaxa.
Wrongful death suits have also been filed over the drug. Wrongful death laws allow surviving family members to sue the party responsible for their loved one's death. Plaintiffs in a wrongful death suit can recover compensation for any medical or funeral expenses, the loss of the deceased's financial support, and the loss of companionship or emotional support.
In January 2014, a federal court selected the first bellwether trials involving Pradaxa. Bellwether trials are a tool used by federal courts to help resolve massive product liability cases involving common issues of facts and similar legal arguments. A judge selects a sample of cases from the overall pool of available cases. The idea is that a sufficient sample size of cases will cover all of the issues that will arise in each plaintiff's case. The purpose of bellwether trials is to provide an indicator to both parties of the anticipated results of future cases.
Injured and Need Legal Advice? Get Free Help Today
If you have a heart condition and take medications, it can be difficult to determine whether a symptom is caused by the illness or the drug. Pradaxa has been blamed for serious side effects, including death, so you may want to get legal advice if you take the drug and have suffered serious complications. Have a qualified product liability attorney provide a free initial review of your claim today.