August 11, 2015 - For several years now, the popular atrial fibrillation drug Eliquis has enjoyed safe status from litigation, while its chief rivals Pradaxa and Xarelto faced over 10,000 claims alleging patients were hospitalized or killed from internal bleeding.
Much of the calm around Eliquis stemmed from clinical studies reportedly showing it was the safest of the three, less likely to cause patient injury or death, and much safer than the traditional alternative warfarin.
But that tide has changed suddenly with two new lawsuits filed last month alleging the makers of Eliquis, Pfizer and Bristol-Myers Squibb, hid some clinical trial data that may show the drug is not as safe as advertised.
Eliquis was approved by the FDA in late 2012, a year after Xarelto and two years after Pradaxa. It is now prescribed to prevent strokes in those with a-fib as well as the prevention of repeat blood clots in the lungs and extremities.
After a slow start in 2013 with only $146 million in sales, use of Eliquis surged in 2014 to $774 million in sales. It is expected to break the $1 billion mark this year. Experts believe doctors are prescribing it more as thousands of lawsuits piled up against Pradaxa and Xarelto.
The first case was filed by a widow on July 24th in New York federal court. She alleged that her late husband, Donald Herschell, died from a massive episode of gastrointestinal bleeding after taking Eliquis for only 3 months. He was 60 years old at the time.
Herschell was admitted to the hospital when his internal bleeding began, but doctors were unable to stop it and he died that day. One reason is that, unlike with warfarin, Eliquis doesn’t have an antidote to stop bleeding in emergencies.
The second case was filed days later, on July 28th in Alabama federal court, by Lester Baldwin, a patient who survived severe internal bleeding while on Eliquis, but only after hospitalization and extensive treatment. Baldwin suffered an intracranial hemorrhage, or brain bleed, while taking the drug.
Perhaps most troubling about these lawsuits are the allegations that Pfizer and Bristol-Myers Squibb covered up the true dangers of Eliquis to promote greater sales.
In the Herschell case, the companies are charged with marketing Eliquis as a one-size-fits-all treatment, when it should really be monitored and tested on a monthly basis to adjust dosage levels. The complaint also alleges that the manufacturers concealed and changed data about the drug’s side effects when it was presented to the FDA for approval.
In his lawsuit, Lester Baldwin also claims that Pfizer and BMS hid data from the FDA, which came from a large-scale study in China and could show greater risks of internal bleeding than previously thought.
The first case is Herschell v. Bristol-Myers Squibb et al, Southern District of New York, Docket No.: 1:15-cv-04620 (2015).
Due to the growing use of Eliquis, and potential that the drug’s true risks were not disclosed to patients, lawyers anticipate that hundreds of families may eventually come forward to file claims and obtain an Eliquis settlement. As an example, those who sued Pradaxa maker Boehringer Ingelheim shared in a $650 million settlement.
For now, the investigation continues into whether the manufacturers covered up Eliquis risks. However, lawyers are providing help to those injured at no cost, and can talk about your specific case today. Call us for more details.
Godoy, J. Bristol-Meyers, Pfizer Sued Over Blood Thinner Death. Law360. (July 24, 2015). Retrieved from http://www.law360.com/lifesciences/articles/683295?nl_pk=83e33034-cf7d-4fc2-9414-39cf205540e6&utm_source=newsletter&utm_medium=email&utm_campaign=lifesciences
Harris Martin Publishing. Alabama Man Accuses Eliquis Makers of Fraud, Says Anticoagulant Caused Brain Hemorrhage. (July 30, 2015). Retrieved from http://harrismartin.com/article/19767/alabama-man-accuses-eliquis-makers-of-fraud-says-anticoagulant-caused-brain-hemorrhage/
This past spring, the FDA issued a warning affecting the millions of patients each year that undergo routine gastrointestinal, gynecologic...
In the latest Invokana lawsuit update, DrugNews has learned that a federal judicial panel has transferred new cases alleging...