German pharmaceutical giant Boehringer-Ingelheim got some very unwelcome news just before the new year. Unfortunately, it wasn't about lawsuits, fines and penalties. It was about the competition. As one of its final actions for 2012, the U.S. Food and Drug Administration approved the anti-coagulant drug apixaban – a product that Bristol-Myers Squibb and Pfizer sells under the brand name Eliquis.
If you have been prescribed a dangerous drug or received a defective medical device – such as a hip or joint implant or a pelvic mesh, both of which have been demonstrated to cause serious health problems – you understand that you have a right to sue the manufacturer for damages.
Recently, global pharmaceutical giant Boehringer-Ingelheim (BI) posted a press release (dated 10 December 2012) on numerous sites on the World Wide Web, proclaiming triumphantly that
“Results from a new post-hoc analysis of the landmark RE-LY® trial show that in patients experiencing a major bleeding event, treatment with Pradaxa® (dabigatran etexilate) was associated with lower mortality and a shorter length of stay in intensive care compared to warfarin.”
Nearly three years since the contemptible and outrageous Citizens United v. FEC ruling by the U.S. Supreme Court – which gave corporations (both foreign and domestic) the right to give unlimited amounts of money to political candidates and campaigns (anonymously) under the guise of “free speech” - a federal court has handed down yet another questionable decision that could affect the rights of patients and the ability of government to hold pharmaceutical corporations accountable.
It's already been called “Citizens United Redux.”
There is no question that dabigatran – produced by German pharmaceutical giant Boehringer-Ingeheim (BI) and sold under the brand name Pradaxa – is dangerous and has resulted in fatal hemorrhaging in as many as 10% of patients for whom it has been prescribed. Most recently, a 92-year-old patient died prematurely after ingesting only a single dose.
Has Boehringer-Ingelheim experienced a “Come to Jesus Moment”?
Several news sources recently announced that the German pharmaceutical giant, whose flagship product Pradaxa has been implicated in several cases of fatal bleeding, has issued a recall – of Pradaxa.
In a recent update to last year's safety warning, the U.S. Food and Drug Administration (FDA) has determined that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.” The update adds that the information is “consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).”
On Wednesday, 3 October 2012, attorneys for the Pradaxa victims and German pharmaceutical company Boehringer-Ingelheim (BI) met before the the Honorable Judge David Herndon. This meeting was the culmination of months of negotiation between the two sides, and among other issues, established numerous deadlines for the completion of steps leading to five “bellwether trials.” These trials will set precedents for other Pradaxa cases going forward.