Boehringer Ingelheim Pharmaceuticals must pay a nearly $1 million fine after a judge ruled it failed to preserve files crucial to the company’s upcoming litigation against its blood thinner Pradaxa.
U.S. District Judge David Herndon, who is presiding over more than 1,700 consolidated cases against Boehringer, last week ordered the German family-owned drugmaker to pay a sanction of more than $931,000, citing inadequate record keeping.
According to Bloomberg News, Herndon ordered the pharmaceutical company to pay the nearly million-dollar fine because executives acted "in bad faith" by allegedly allowing 500,000-plus documents to disappear.
"The wrongs here are egregious," Herndon said in the ruling. He scolded the company, calling its lack of safeguarding documents a "gross inadequacy."
Plaintiffs’ attorneys are seeking the files connected to the development and marketing of the blood thinner. Pradaxa carries bleeding risks, and has been linked to more than 500 deaths and thousands of complications since it was put on the market in October 2010.
Those suing the company say Boehringer promoted the drug as better than already existing anticoagulants while knowing the drug had potentially fatal risks of bleed-out deaths.
Missing Files Blamed on IT Issues
The accusations as to why the company failed to produce the files for prosecuting attorneys range from "misrepresentations" about efforts to preserve files to the company allowing information to be destroyed.
Boehringer Ingelheim blames a series of technology errors for the missing information they were asked to present to prosecuting attorneys. In one instance, the pharmaceutical company blames a Microsoft Windows 7 update for erasing a hard drive that contained some of the requested files.
The judge also slammed the company for failing to save text messages sent and received on company phones, which were set to auto-delete. Pertinent evidence was allegedly removed from employee's personal phones, too.
According to Bloomberg Businessweek, a spokesperson for the drug maker acknowledged technical issues in an email stating, "Boehringer Ingleheim has acknowledged that we have had unintentional and unexpected problems with discovery in this litigation."
Boehringer claims it has already made 32 million pages of information about Pradaxa available, even arguing that many of the documents requested are not relevant to the case.
The drug company could possibly face additional sanctions from the judge if it fails to turn over the missing files. If Boehringer can't produce them, the company must tell the court it is "unable to comply with the order."
Safety Questions Persist About PradaxaPradaxa is primarily taken by patients to prevent strokes and blood clots.
Warfarin, which is popularly sold under the brand names Coumadin and Jantoven, was the most prominent blood thinner in the market since the 1950s. A less popular intravenous blood thinner called Heparin has also been sold since 1936.
Pradaxa’s alleged benefit was that it required less maintenance than warfarin and has fewer side effects. Boehringer spent nearly half a billion dollars promoting the drug. Pradaxa already has more than $1 billion in sales after only a few years on the market.
Evidence that Pradaxa is potentially dangerous surfaced in 2011. According to the U.S. Food and Drug Administration, 542 people died from the drug, and nearly 4,000 more people experienced side effects after a year of taking it.
Pradaxa was also frequently mentioned in the FDA's adverse event reports that same year.
Some of the lesser side effects include nausea, heart burn and stomach pain. Besides heavy bleeding, other serious ones include swelling and joint pain, bruising and unusually dark vomiting.
Published studies also found that Pradaxa users were more at risk for heart attacks and chest pain.
The FDA released a November 2012 report that Pradaxa does not pose a higher bleeding risk than warfarin. However vitamin K can stop the bleeding for people who take warfarin. There is no drug that can reverse Pradaxa’s bleed-out effects.