Judge Fines Pradaxa Drugmaker $1M over Missing Files
Posted in Drug & Medical Devices on December 12, 2013
German pharmaceutical company Boehringer Ingelheim has been fined $931,000 in federal court for withholding or failing to preserve documents sought by plaintiffs in hundreds of Pradaxa lawsuits.
According to court documents, Boehringer failed to preserve or produce files belonging to a high-level scientist, sales representatives, consultants and others. The drugmaker also failed to provide access to documents on their computer network and allowed text messages to be deleted.
U.S. District Judge David Herndon, overseeing the multidistrict litigation, called the wrongs “egregious in the eyes of the Court.” In his scathing 51-page decision, Herndon ruled that Boehringer executives acted “in bad faith,” calling their defenses unbelievable and “nonsense.”
This was not the first time Boehringer has been sanctioned for failure to comply with a court order during the trial. In his September 18, 2013 decision, Judge Herndon imposed a $29,540.00 fine – one he thought would remedy the discovery abuses and prevent them from occurring in the future.
The judge’s patience had obviously worn thin as he imposed the nearly $1 million in additional fines on Monday, “Once again, the defendants do not get to choose which evidence they want to produce and from which sources.”
The FDA approved the anticoagulant Pradaxa (dabigatran) in 2010 for the prevention of stroke in patients with atrial fibrillation. Just one year later, there were 3,781 reports of serious adverse events, including 542 patient deaths. According to the Institute for Safe Medication Practices, Pradaxa surpassed all other regularly monitored drugs in reports of hemorrhage (2,367 cases), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure.
Court records indicate more than 1,700 lawsuits have been filed in the Southern District of Illinois on behalf of alleged victims of Pradaxa bleeding. Boehringer Ingelheim is accused of concealing knowledge about the drug’s risks. Plaintiffs also allege that the company failed to provide adequate warnings regarding the lack of an effective antidote for Pradaxa bleeding.
The case is titled In re Pradaxa Products Liability Litigation, 12-MD-02385-DRH-SCW, U.S. District Court, Southern District of Illinois (East St. Louis). The first bellwether trial in the Pradaxa Multi District Litigation is currently scheduled for August 2014.
“Boehringer to Pay $931,000 Fine Over Lost Pradaxa Files” by Jef Feeley and Phil Milford, Bloomberg News, December 10, 2013.