Drugwatch reports that drugmaker, Boehringer Ingelheim, is on the hook for nearly $1 million after a judge ruled the German-based company lost documents crucial up upcoming litigation concerning the anticoagulant Pradaxa (dabigatran).
U.S. District Judge David Herndon ordered Boehringer to pay $931,000 because company executives allowed a half million documents to just disappear. At the very least the judge decided the company was guilty of a “gross inadequacy” of record keeping which it did “in bad faith.”
What was lost?
In litigation, it’s important to show what a company knew about a defective drug and when they knew it. If they failed to warn doctors, did not include in the label all of what they knew about patient risks and safety, or outright hid damaging scientific data, all of this must come out before a jury which will weigh the damage done by corporate secrecy. Generally some sort of cover-up does not bode well for a company but sometimes paying a fine is easier than fessing up to the truth.
Pradaxa is an anticoagulant that requires less monitoring than the popular Coumadin (warfarin), the standard since the 1950s. All blood thinners are prescribed to reduce the risk of stroke and blood clots. Unlike Coumadin, Pradaxa does not have an antidote. In the unfortunate case of trauma or a cut that might causing bleeding, either externally or internally, medical professionals cannot stop the bleeding.
Had more truthful information been made public, we might not be seeing the deaths of more than 500 patients and thousands of complications. That is a very bad record since the drug has only been on the market since October 2010.
What is the company’s excuse? Boehringer blames a Microsoft Windows update for erasing important documents. Unfortunately among the missing documents are e-mails circulated within the company. Apparently the phones were set to auto-delete. So often we find that private e-mails tell the story of a plan hatched within a company to cover its behinds. Boehringer Ingelheim tells Bloomberg Businessweek the company “has acknowledged that we have had unintentional and unexpected problems with discovery in this litigation,” even as it had made millions of pages of discovery available.
If the company is ultimately unable to comply with the order from Judge Herndon, additional sanction could be filed.