German drug maker Boehringer Ingelheim issued a press release this week boasting that its popular blood thinning drug Pradaxa has been approved in the 100th country for stroke prevention in atrial fibrillation patients.
Unfortunately, Jordan, that lucky 100th country, may have no idea about the bad press that has followed Pradaxa in recent months.
Numerous experts have warned that Pradaxa may have higher rates of internal bleeding injury and death than traditional blood thinner warfarin.
As of this year, over 2,000 families have filed lawsuits in a special U.S. federal court after loved ones suffered internal bleeding hospitalization, injury or death.
U.S. District Judge David Herndon, who is presiding over the Pradaxa lawsuit, recently fined Boehringer nearly $1 million for failing to produce evidence.
In January, the FDA announced it would launch a new investigation to compare the safety of Pradaxa and warfarin. This came just before a report that the company had withheld data from the initial clinical trials used for approval that would have shown higher than expected bleeding rates.
In February, internal documents released by the court also showed Boehringer executives pushed for the suppression of an internal study that revealed Pradaxa may have higher bleeding or stroke rates for some patients. The study, which concluded blood testing would benefit many patients, was withheld as it could hurt marketing and sales of the drug.
Last month, Boehringer’s own website, Pradaxa.de, admitted the company has been informed of 10,798 instances of major internal bleeding among Pradaxa users through the end of last year. 1,646 of these were fatal. Unfortunately, the company didn’t share this data on U.S. sites or with the public.
Now, all of this information is set to be introduced in court as Judge Herndon has scheduled the first Pradaxa lawsuit trial to start in August. Four cases have been selected as bellwether cases, or test cases, to gauge how litigation will go in the future.
Patient advocates have called for a Pradaxa recall, or at least new label warnings on the drug. However, for now, the only recourse for victims is legal action after injury.
If you or a family member suffered internal bleeding while taking Pradaxa, it is important to speak with a lawyer. It costs nothing to discuss your case or file a claim. However, time is limited.
Due to the complex nature of these cases, DrugRisk only recommends lawyers who have already handled Pradaxa lawsuits. Contact us today for more information or to speak with a lawyer.