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Canadian Clinical Drug Trials at Issue in U.S. Pradaxa Lawsuits

Feb 20, 2014

In an unprecedented situation, Canada’s McMaster University and Hamilton Health Sciences are facing lawsuits in the United States over the safety of the drug Pradaxa (dabigatran). The lawsuits allege that regulatory approval for the popular anticoagulant was partly based on tainted data from clinical trials led by Hamilton researchers.

Pradaxa is an anticoagulant hailed by some heart specialists as a safe, easy alternative to warfarin, prescribed for decades for patients at risk of stroke because of atrial fibrillation, a common type of heart arrhythmia, The Spectator reports. Warfarin requires regular blood testing and carries dietary restrictions because of its interactions with certain foods and other medicines, according to the package insert. Pradaxa does not currently have these restrictions.

Nearly 2,300 plaintiffs — or the estates of those who have died — allege they were harmed by Pradaxa. They have brought suit again German pharmaceutical company Boehringer Ingelheim, the developer of Pradaxa, according to The Spectator.

Federal judge David Herndon, who oversees the cases, has selected four bellwether cases to be the first ones tried. The first trial is scheduled to begin August 11, according to The Spectator. The results of these cases could lead to the resolution of all the cases. McMaster University, Hamilton Health Sciences and their jointly operated Population Health Research Institute are co-defendants in some cases. The institute ran the lone clinical trial for Pradaxa, the RE-LY trial, which resulted in the drug's approval in Canada and the United States. The drug reached blockbuster status in just three years, with annual sales topping $1 billion, according to

In the lawsuits, Boehringer Ingelheim faces allegations 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 equally serious allegations: negligence, negligent misrepresentation, fraud and fraudulent concealment. Court documents say the three organizations did not adequately design and administer the clinical trial, did not maintain trial data, and did not report serious adverse effects. An attorney for the plaintiffs told The Spectator, “This is a safety issue, [and] it's a public health issue."

Judge Herndon recently unsealed documents that reveal Boehringer Ingelheim’s attempts to quash results of an internal study it feared would damage Pradaxa sales. Pradaxa does not require blood tests – one of the drug’s strong selling points – but the study results suggested that many Pradaxa users do in fact need blood testing because metabolic differences may result in patients, especially older ones, having too little or too much of the drug in their bloodstream, The New York Times reported. Too low a level means the patient is inadequately protected; too high a level means an elevated risk of excessive bleeding.

The Times reports that Pradaxa, which has been prescribed to some 850,000 patients, has been linked to more than 1,000 deaths. Late last year the U.S. Food and Drug Administration (FDA) announced it would undertake a reassessment of Pradaxa as compared to warfarin.

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