Playing hide and go seek is a harmless kid’s game. Playing hide and go seek with information that affects people’s lives is a completely different matter.
Recently unsealed court records from thousands of lawsuits filed by patients who claim their use of the popular blood-thinner Pradaxa caused them to suffer life-threatening internal bleeding problems show that the medication’s manufacturer hid critical information about this dangerous side effect from government regulators.
The papers surfaced during pre-trial evidence gathering in a massive federal court litigation involving these claims against Boehringer Ingelheim and the company’s actions in marketing Pradaxa.
Patients and families of victims who died allegedly as a result of Pradaxa use are claiming that company officials were aware of deadly Pradaxa side effects at the time it was approved by the U.S. Food and Drug Administration in 2010 but failed to provide important data to the FDA.
According to a deposition taken of a high-ranking Boehringer Ingelheim official the company was aware of the fact that over 1,400 people had suffered fatal internal bleeding problems from their use of Pradaxa before the FDA approval.
As Bloomberg News reported about the court filings:
“Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.
“Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show.
“The Food and Drug Administration was reviewing the bleeding as part of a safety check spurred by results seen in adverse incident reports sent to the agency. Andreas Clemens, an executive who oversees Pradaxa, acknowledged the Ingelheim, Germany-based company shared only one of the analyses and said he couldn’t say why, according to the unsealed court filings.”
Bloomberg also reported that the company is facing more than 2,000 lawsuits involving Pradaxa, a treatment used to prevent strokes in patients who suffer from atrial fibrillation, a heart-rhythm disorder.
FDA regulators cleared the drug, which generated $1.4 billion in 2012 sales, as the first alternative to warfarin, a product sold by Bristol-Myers Squibb Co. under the brand name Coumadin that’s been used for 50 years to avert strokes caused by blood clots, according to the report.