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Lost Pradaxa Files Cost Boehringer Nearly $1M in Fines

Dec 12, 2013

Drug maker, Boehringer Ingelheim GmbH, has been charged with a nearly $1 million fine, a judge has ruled, for withholding or failing to preserve files sought in litigation.

The “countless” files, Bloomberg News reports, were sought by patients who filed lawsuits over Boehringer’s blood thinner, Pradaxa. U.S. District Judge David Herndon, located in East St. Louis, Illinois, is overseeing more than 1,700 consolidated lawsuits brought over allegations that Pradaxa caused excessive and, in some cases, deadly bleeds. Judge Herndon concluded that executives at Boehringer acted “in bad faith” when they failed to ensure that the documents and files concerning the development and marketing of Pradaxa were preserved.

“The wrongs here are egregious,” Judge Herndon said in the ruling. “The gross inadequacy” of the company’s efforts to safeguard the documents justified a sanction of more than $931,000 against Boehringer, he added, according to Bloomberg News. Boehringer is readying for the first federal court trial brought over claims that that the drug maker hid Pradaxa’s bleeding risks. The first consolidated case was set by Judge Herndon for trial in August; other cases are pending in Delaware, California, and Illinois, Bloomberg News reports.

“Boehringer Ingelheim has acknowledged that we have had unintentional and unexpected problems with discovery in this litigation,” Mary Lewis, a spokeswoman for the drug maker, wrote in an emailed statement. “We do not believe these problems have prevented the plaintiffs from obtaining access to a very wide range of documents regarding Pradaxa, including the central science, safety, and regulatory documents regarding the medicine,” she said, according to Bloomberg News.

Patients and their families allege Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought the drug to the United States market in October 2010, writes Bloomberg News. Pradaxa is different from other blood thinners because there is no antidote to its effects, which can lead to fatal bleeding events.

For about five decades Coumadin (warfarin), which is an anticoagulant, was prescribed to patients who were diagnosed with atrial fibrillation (AF), which is an irregularity of the heartbeat. The drug is also prescribed to people who are at increased risk for developing potentially deadly blood clots.

Pradaxa is a blood thinner used to reduce risks of stroke and blood clots in patients with non-valvular AF, which is a common heart rhythm abnormality. Pradaxa is not cleared for use in patients who are diagnosed with AF caused by heart valve problems. Pradaxa inhibits thrombin, which is, according to News-Medical, the central coagulation activator in the body’s blood clotting system.

While both Pradaxa and warfarin can cause internal bleeding, there are readily available antidotes for warfarin bleeds. Mounting Pradaxa bleeding lawsuits allege the drug caused serious, uncontrollable bleeding side effects that include GI bleeding and cerebral hemorrhaging for which there is no possible reversal or reversal agent.

Plaintiff attorneys allege that Boehringer officials marketed the drug as superior to other blood thinners, yet knew Pradaxa was not better than similar drugs. Meanwhile, the blood thinner has been tied more than 500 deaths in the U.S. over a two-year period. Issues with Pradaxa. U.S .Food and Drug Administration (FDA) officials say, have involved 542 reports of fatalities and 3,781 side-effect incidents in 2011.

Boehringer executives must also provide files sought by plaintiffs’ attorneys that are in their possession or they must officially advise the court that they are “unable to comply with the order,” Judge Herndon said. He also said he may consider additional sanctions over the missing files, according to Bloomberg News.

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