The number of lawsuits against the manufacturer of the oral anticoagulant, alleging that the drug caused internal bleeding injuries or death, have risen significantly during the last two months. A prescription drug patient resource center reports a 29 percent rise in Pradaxa lawsuits, according to PRWeb.
Pradaxa, a drug prescribed to reduce the risk of stroke, particularly in patients with atrial fibrillation, is manufactured by the German-based international pharmaceutical company Boehringer Ingelheim. In the U.S., the drug has been linked to more than 500 deaths, yet there has been no Pradaxa recall. The drug remains on the market as a “safe” drug.
Court records show that the number of cases filed against Boehringer Ingelheim increased nearly 30 percent from 1,133 on July 10 to 1,470 by September 11.
Pradaxa was approved by the FDA in 2010 as an alternative to the existing anti-clotting drug warfarin (brand name Coumadin). Unlike warfarin, there is no antidote to reverse the blood-thinning effects of Pradaxa. Boehringer Ingelheim has claimed that their drug is equally as safe as warfarin – a claim that attorneys litigating the products liability action in the U.S. dispute.
“We have some very serious concerns about the integrity and reliability of the data from Pradaxa’s clinical trials,” said attorney Ned McWilliams of Levin, Papantonio, who practices in the areas of product liability and bad drug litigation.
According to attorneys, the drug was not needed in the U.S. market; however the manufacturer saw an opportunity for a “cash cow.” Boehringer Ingelheim knew that their product was much riskier than warfarin, as there is no known reversal agent for the blood-thinning effects of Pradaxa.
The company marketed their drug as an easier alternative to warfarin by telling doctors and patients that no medical monitoring was needed with their drug, but failed to stress the risks associated with Pradaxa.
“The problem with Pradaxa, and its hasty approval, lies in the fact that, unlike warfarin – the drug it is compared to in both its clinical trials and television advertisements – is that it cannot be reversed. Or to put another way, it has no antidote,” Mr. McWilliams continued.
The drug was approved by the FDA in 2010, and, earlier this year, Boehringer Ingelheim filed for additional marketing approvals from the FDA. And in June, the company asked European regulators to approve wider use of its drug in the European market.
In November 2012, Boehringer Ingelheim issued a nationwide voluntary recall of a single manufacturing lot of Pradaxa, not because of the dangerous effects of their drug, but due to “a potential packaging defect” in one specific lot. The recall stated that patients should continue to take Pradaxa as directed until they obtained replacement pills, and that they believed “most of the potentially affected bottles [had] been returned.”
Boehringer Ingelheim is a corporate funder of the American Legislative Exchange Council (ALEC), a bill mill that allows corporate interests to push bills that undermine healthcare reform efforts, among many others.
Last year, the company was forced to pay $95 million to federal and state governments for illegally promoting some of its drugs for unapproved uses and dosages. Around the same time, the company settled allegations that they paid kickbacks to doctors and healthcare providers.