Nashville Pradaxa Lawyer
After its approval for prescription use by the U.S. Federal Drug Administration (FDA) in 2010, Pradaxa was hailed for its effectiveness in preventing the formation of blood clots. Unfortunately, shortly thereafter, the FDA received numerous reports of serious complications in patients who had taken Pradaxa. In some devastating cases, use of the drug was linked to fatalities. The situation led many victims to file lawsuits against the manufacturer of the drug, claiming that it failed to warn users of side effects. If you were the victim of hemorrhage, uncontrolled bleeding, or other effects from taking Pradaxa, it is essential to consult with a knowledgeable Nashville Pradaxa lawyer who can assist you in seeking compensation for your losses.
Complications and Side Effects from Pradaxa Use
The human body’s natural response to bleeding is to form clots, but this effort can go too far. Serious medical conditions, including strokes and heart attacks, can result from overproduction of the agent that cause clots. Pradaxa counteracts this phenomenon by blocking the agent, called thrombin. Though it is highly effective in preventing dangerous clots, the drug also disables the body’s ability to stop bleeding when the patient suffers internal injuries. Therefore, users of Pradaxa may experience:
- Heart failure;
- Liver failure;
- Abdominal distress;
- Brain hemorrhage;
- Central nervous system bleeding;
- Kidney failure;
- Gastrointestinal distress and ulcers;
- Severe allergic reactions, including rash;
- Gastroesophageal reflux; and,
- Other serious reactions.
Any of these medical conditions can have serious health implications, while many may be life-threatening or fatal.
Drug Manufacturers’ Failure to Warn
Pharmaceutical companies must comply with regulations established by the FDA and other legal requirements when producing prescription medications such as Pradaxa. One of these obligations is engaging in a rigorous process of testing the drug before it is released for consumer use; another is warning the public about the known risks associated with taking the product.
In the case of Pradaxa, critical discrepancies arose between the test findings released by the manufacturer and the real-life use in clinical practice. In addition to improperly incorporating trial data, the drug maker also failed to properly manage such pharmacovigilance responsibilities as adverse-event reporting and post-marketing monitoring. As a result, there were challenges in identifying certain risk factors for taking Pradaxa.
Regarding the duty to warn, victims allege that the manufacturer of Pradaxa:
- Misrepresented the safety and effectiveness of the medication as compared to other drugs;
- Engaged in deceptive marketing practices;
- Failed to properly label the drug in regards to dosing details;
- Did not indicate an antidote to counteract the effects of uncontrolled bleeding in patients who took the drug;
- Failed to properly research Pradaxa, especially in the context of variables that may be present when recommending dosage.
Victims’ lawsuits did not make it to trial, as the manufacturer of Pradaxa settled these claims out of court. Boehringer Ingelheim paid out $650 million to resolve approximately 4,000 actions in federal and state courts.
Schedule a Consultation with a Skilled Nashville Pradaxa Lawyer
If you would like to hear more about your rights in a Pradaxa-related case, please contact Fox Willis Burnette, PLLC at (866) 862-4855. We can set up a consultation with an experienced dangerous drug lawyer who can tell you more about your legal remedies.