A Second Order Cover Up? - Judge Finds Boehringer Ingelheim Allowed Destruction of Records Bearing on Allegations of Cover Up of Drug Adverse Effects

This case generated little coverage, a story in Bloomberg, and a post on PharmaLot, but perhaps should have received more attention.Background - the Pradaxa Case The background, per Bloomberg, is thatBoehringer [Ingelheim BmbH] is preparing to face the first federal court trial of claims that it hid Pradaxa’s bleeding risks. Pradaxa is dabigatran, a new anti-coagulant drug that can be used without frequent monitoring of blood tests, as is required when using the older drug warfarin.  However, unlike warfarin, the effects of dabigatran cannot be quickly reversed should a patient on the drug start to bleed. The reason for the trial is thatPatients and their families alleged that Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, which can lead to so-called bleed-out deaths. Pradaxa has generated more than $1 billion in sales worldwide for Boehringer, the world’s biggest family-owned drugmaker. Researchers have found it more effective at preventing strokes than older competitors, including Bristol-Myers Squibb Co.’s Coumadin. Consumers’ lawyers contend that Boehringer officials marketed the drug as superior to existing blood thinners when they knew its performance was not better than similar medicines. Pradaxa has been linked to more than 500 U.S. deaths over a two-year period, and Bo...
Source: Health Care Renewal - Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception Pradaxa warfarin Source Type: blogs