As we have discussed previously with our readers in Birmingham, central to most of the lawsuits filed by former users of the drug Pradaxa against Boehringer Ingelheim, the drug's manufacturer, is that the company failed to warn patients that Pradaxa can cause severe side effects for which no antidote is available. That product liability argument is rooted in the lack of detailed warning provided on the medication's packaging until April 2012.
At that point, Pradaxa "updated" the warning label to more specifically inform patients that the drug could cause uncontrolled bleeding, which can be fatal. Symptoms can include bleeding in organs, even the brain. Competing anticoagulant drugs like warfarin come with antidotes to reverse the bleeding. But Boehringer did not develop an antidote prior to releasing Pradaxa on the U.S. market. As a result, in many cases doctors have struggled to stop bleeding in Pradaxa patients. The Food and Drug Administration said that 542 people died due to Pradaxa in 2011, the most fatalities of any drug last year.
Despite this, critics say, Boehringer sought to minimize the risks to users. The company eventually admitted that the number of Pradaxa deaths were five times greater than it originally claimed. Anticoagulants generally carry potentially side effects, but Boehringer seeking to shift blame for this high number of fatalities suggests that it was thinking of business over patient safety.
Besides fatal injuries, the FDA reported hundreds of serious non-fatal injuries like stroke and acute renal failure. Such injuries can cause long-term disabilities, likely leading to high medical and other bills.
Source: Injury Lawyer News, "Lawsuits Alleging Pradaxa Side Effects Joins Illinois MDL," Perry Larkin, Nov. 20, 2012
· Our law firm represents clients who were harmed by defective drugs or other products. For more information, please visit our Birmingham product liability page.