The first lawsuits alleging injuries and deaths from use of the dangerous drug Pradaxa were recently filed against manufacturer Boehringer Ingelheim. Eight individual suits have been filed in federal courts in Tennessee, Oklahoma, Kentucky and Louisiana–states that have very short statute of limitations for filing pharmaceutical lawsuits against drug makers. These lawsuits include claims against Boehringer for negligent design, negligent manufacture, failure to warn, strict liability, breach of warranty, and violations of state consumer protection laws.
Plaintiffs’ attorneys expect that a multi-district litigation (“MDL”) will soon be established to consolidate lawsuits arising from this dangerous drug. It is possible that an MDL for Pradaxa claims could be based in Connecticut because Boehringer’s United States headquarters are located in Ridgefield, Connecticut.
Although Praxada was only approved by the Food and Drug Administration (FDA) in October 2009, 505 cases of hemorrhaging have already been reported to the FDA in the first quarter of 2011. In a study by the Institute for Safe Medication Practices (ISMP), it was reported that 272,119 Pradaxa prescriptions were dispensed in the first quarter of 2011. The ISMP study found that 932 serious adverse events were reported, including 120 deaths, 25 cases of disability, and 543 hospitalizations.
In addition, the results of seven clinical trials published in the Archives of Internal Medicine in January 2012 found that Pradaxa was “significantly associated with a higher risk” of myocardial infarctions (heart attack) and acute coronary syndrome.
When the drug manufacturer was asked for comment, Boehringer acknowledged that it was aware of a large number of serious adverse drug events connected to Pradaxa. Boerhinger “attributed the report volume in part to the rapid acceptance of the drug into the market and an active sales force with extensive contact with physicians, resulting in more frequent reports.”
The ISMP noted that elderly patients are at greater risk of adverse events, adding that one-fourth of the affected patients were 84 years old or older. “While more study is needed, it may turn out to be a major drug safety mistake for the FDA to have approved a one-dose-fits all drug intervention as risky and sensitive as an anti-coagulation in older patients,” said Thomas Moore, ISMP senior scientist.
For more information, contact the Ohio Pradaxa lawyers at Clark, Perdue & List.
Source: Pharmalot, “Pradaxa Side Effect Reports Were Hemorrhaging,” Ed Silverman, January 11, 2012.