Pradaxa Lawsuits: Our Florida Personal Injury Law Firm Will Aggressively Pursue Your Claim
The Pradaxa lawyers at Searcy Denney Scarola Barnhart & Shipley have more than 30 years of experience representing clients harmed by unsafe pharmaceuticals. Our team understands the physical and emotional toll on patients and families when a patient who is prescribed a drug to alleviate a medical problem suffers serious, life-threatening side effects. Our Florida Pradaxa lawyers have earned a reputation for meticulous investigation, thorough preparation, and aggressive representation of our clients.
Due to the large number of adverse side effects reported in the first quarter of 2011, the number of lawsuits relating to Pradaxa – a new oral anticoagulant approved by the FDA in October 2010 and marketed as an alternative to warfarin – is likely to increase.
An Institute for Safe Medication Practices’ safety alert reported Pradaxa caused 932 serious adverse events including:
- 120 deaths
- 25 cases that resulted in permanent disability
- 543 adverse reactions that required hospitalization
- 505 cases of these events involved hemorrhaging.
These serious side effects have led to a post-market evaluation by the FDA of Pradaxa’s safety and effectiveness. In January 2012, the FDA required Pradaxa manufacturer Boehringer Ingelheim to update its Pradaxa label to add information regarding the dangers of bleeding events and the lack of a reversal agent. The drug does not yet carry a “black box” warning or recall. Side effects of Pradaxa also have prompted a labeling update in Europe and safety advisories in Japan and Australia.
If you or someone you know is experiencing side effects as a result of taking Pradaxa, contact an experienced Pradaxa personal injury lawyer to evaluate your case.
First Federal Lawsuits Relating to Pradaxa® Side Effects Filed in March 2012
Three landmark federal court Pradaxa lawsuits were filed in March 2012 in federal district courts in Louisiana, Tennessee, and Kentucky. Pharmaceutical companies are responsible for ensuring that their products are safe and free of any unknown serious side effects. In the case of negligence regarding Pradaxa, you may be able to collect financial compensation for your injuries.
Was Pradaxa® Manufacturer Negligent in Reporting Danger of Product?
Boehringer Ingelheim Pharmaceuticals, Inc. has extensively marketed Pradaxa as superior to warfarin, the standard treatment prior to the release of Pradaxa. Allegations have been raised about flaws in the drug’s large clinical trial and the manufacturer’s failure to adequately warn consumers about the risks of serious side effects. Patients and families who have experienced serious problems as a result of Pradaxa should consider pursuing a lawsuit as a result of the company’s inadequate drug research or its failure to warn about the risk of serious and potentially life-threatening side effects.
The Institute for Safe Medication Practices (ISMP) reports that the Pradaxa manufacturer was aware of the large number of adverse events reported and that, within a few weeks of its approval, Pradaxa was named in more FDA side effect reports than over 98% of the medications monitored. The ISMP also found that Pradaxa is already being used off-label extensively; only a third of prescriptions written since Pradaxa’s approval have been for the FDA-approved indication (stroke prevention in patients with atrial fibrillation).
Boehringer Ingelheim’s own RE-LY® Trial, produced results that will likely play a part in allegations that it failed to sufficiently warn consumers about Pradaxa’s risk of life-threatening and fatal side effects even though package inserts contain a warning. The trial, which compared Pradaxa to warfarin use in 18,000 patients, showed increased incidence of bleeding, gastrointestinal events, and heart attack. Drug safety watchdog group Therapeutic Initiative evaluated the trial and concluded that “licensing of dabigatran 150 mg BID for atrial fibrillation is premature, pharmacologically irrational and unsafe for many patients.” The group suggests that an independent audit of the trial be conducted to further evaluate optimal dosage, side effects, and “irregularities in conduct and sources of bias.”
Wrongful Death Suit Filed Against Pradaxa® Manufacturer
Pradaxa lawsuits may raise questions about the drug being marketed as a superior alternative to warfarin. Considering the lack of a bleeding antidote for patients taking Pradaxa, as Vitamin K is for patients taking warfarin, patients taking Pradaxa are at a higher risk for serious side effects.
A wrongful death lawsuit filed in Tennessee by the family of a woman who suffered a fatal gastrointestinal bleed alleges that Pradaxa caused her death. The woman was hospitalized for the bleed but was released and subsequently died less than three months after she began using Pradaxa in January 2011. The lawsuit alleges that Boehringer Ingelheim, Pradaxa’s manufacturer, created a defective product that is no safer than older blood thinners [warfarin], and lacks a reversal agent for bleeding. The lawsuit argues that information regarding the lack of an antidote was “buried in small print in a medication guide under the heading of ‘overdose’” and that Boehringer did not provide guidance pertaining to bleeding incidents. The complaint also faults the standard dosing for Pradaxa, noting that warfarin is dosed in specification to each patient’s need.
Contact a Florida Personal Injury Lawyer Today
If you or a loved one has suffered adverse side effects as a result of taking Pradaxa, please complete our contact form, or call our Pradaxa lawyers to arrange for a confidential free consultation.