In an unusual situation, Canada’s McMaster University and Hamilton Health Sciences have been named co-defendants in lawsuits in U.S. federal court over the safety of the blood-thinning drug Pradaxa (dabigatran). The lawsuits allege that tainted data from mismanaged clinical trials led by these institutions was used to gain approval for Pradaxa in the United States and Canada.
Pradaxa, Xarelto (rivaroxaban), and Eliquis (apixaban), all recently approved blood thinners, are competing to replace warfarin, the decades-old treatment for patients at risk of stroke because of atrial fibrillation, a common heart arrhythmia. Heart specialists have hailed Pradaxa as an easier to use alternative to warfarin because it does not require regular blood testing, as warfarin does, and there are no dietary restrictions, according to The Spectator.
Since its approval, Pradaxa has been prescribed to about 8500,000 people, but nearly 2,300 Pradaxa users, or the estates of those who died, have filed suit against German pharmaceutical company Boehringer Ingelheim, alleging they were harmed by Pradaxa. McMaster University (in Hamilton, Ontario), Hamilton Health Sciences and the Population Health Research Institute are co-defendants in some of the cases, according to The Spectator. They led the only clinical trial involved in Pradaxa approval in the United States and Canada.
Among the allegations Boehringer Ingelheim faces are claims of gross negligence, misrepresentation, product design defects, failure to warn patients, fraud, and fraudulent concealment. McMaster, HHS, and the Population Health Research Institute (PHRI) face allegations of negligence, negligent misrepresentation, fraud and fraudulent concealment. Court documents claim they did not properly design or administer the clinical trial, did not maintain trial data, and failed to report serious adverse effects. “This is a safety issue, [and] it’s a public health issue,” an attorney for the plaintiffs told The Spectator. The New York Times reports that Pradaxa has been linked to more than 1,000 deaths.
Federal judge David Herndon recently unsealed documents revealing that Boehringer Ingelheim tried to quash an internal study whose results the company feared would damage Pradaxa sales. A major marketing point for Pradaxa is that its use does not subject patients to the inconvenience of regular blood tests. But the internal study suggested that many Pradaxa users do need testing. Metabolic differences, especially in older patients, can result in too much or too little of the drug in the bloodstream, The New York Times reported. Too little leaves the patient inadequately protected against stroke; too much increases the risk of internal bleeding.