Friday, December 13, 2013

Boehringer's "gross inadequacy"

Boehringer Fined $931,000 Over Lost Pradaxa Files

Boehringer Ingelheim GmbH, which markets and manufactures Pradaxa, has been charged with a nearly $1 million fine, according to a recent ruling. The fine was levied for the drug maker’s withholding or failing to preserve files sought in Pradaxa litigation, according to the judge’s ruling.

The “countless” files were sought by patients who have brought lawsuits over the blood thinner, Pradaxa, Bloomberg News reports. U.S. District Judge David Herndon, located in East St. Louis, Illinois, is overseeing more than 1,700 consolidated lawsuits that have been filed over allegations that Pradaxa caused excessive and, in some cases, fatal bleeds. Judge Herndon concluded that Boehringer executives acted “in bad faith” when they neglected to ensure that the documents and files in question, which involved 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 protect the documents warranted a sanction of more than $931,000 against Boehringer, the judge added, according toBloomberg News. Boehringer is preparing for the first federal court trial filed over allegations that it hid bleeding risks associated with Pradaxa. The first consolidated case was set by Judge Herndon for trial in August; other cases remain 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, according to Bloomberg News.Meanwhile, patients and their families allege that Boehringer executives were aware that Pradaxa posed deadly risks to some consumers when the drug was released to the United States market October 2010, writes Bloomberg News. Pradaxa is unlike other blood thinners because there is no antidote to its effects, which can lead to deadly bleeding events.

For some 50 years, the anticoagulant, Coumadin (warfarin), has been prescribed to patients diagnosed with atrial fibrillation (AF), an irregularity of the heartbeat. The drug is also prescribed to people at increased risk for developing potentially fatal blood clots.

The blood thinner, Pradaxa, is 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 diagnosed with AF caused by heart valve problems. The drug inhibits thrombin, which is, according to News-Medical, the central coagulation activator in the body’s blood clotting system.

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

Plaintiffs’ attorneys allege that Boehringer officials marketed the drug as better than other blood thinners, yet were aware that Pradaxa was no better than similar drugs. Meanwhile, Pradaxa has been tied more than 500 deaths in the U.S. over a two-year period and, U.S .Food and Drug Administration (FDA) officials say, Pradaxa has been involved in 542 reports of fatalities and 3,781 side-effect incidents in 2011.

Boehringer executives must either provide the files sought by plaintiffs’ attorneys that are in their possession or 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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