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Boehringer Ingelheim has acknowledged that it now faces more than 2,000 Pradaxa lawsuits filed by patients who say they suffered dangerous, and sometimes fatal, bleeding problems that were allegedly caused by the drug’s lack of a reversal agent.
The number of cases, all in the United States, was first reported by the German newspaper Handelsblatt, and the company confirmed that number on Thursday.
While Boehringer Ingelheim has maintained that the number of bleeding events it has seen are comparable to what was expected in clinical trials, shortly after the anticoagulant was introduced doctors began reporting problems where they were unable to control or reverse bleeding events that developed among patients on Pradaxa.
According to allegations raised in product liability lawsuits filed against the drug maker, Boehringer Ingelheim failed to adequately warn consumers and the medical community about the potential bleeding side effects of Pradaxa, as well as the lack of an antidote to allow doctors to stop the blood thinning effects of the medication. As a result, many doctors were at a loss over what to do to counteract the drug, which may have contributed to worse outcomes from Pradaxa bleeds.
Since August 2012, the federal Pradaxa litigation has been consolidated as part of an MDL, which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts. The company also faces Pradaxa lawsuits in state courts in Illinois, California and Connecticut.
As part of the coordinated management of the cases in the federal court system, Judge Herndon has scheduled a series of early trial dates in the Pradaxa MDL, known as bellwether cases. These trials are set to begin between August 2014 and February 2015, with the outcomes designed to help the parties gauge how juries are likely respond to certain evidence and testimony that may be repeated throughout a large number of cases.
Boehringer Ingelheim Acting in ‘Bad Faith’
During the discovery phase of the litigation, Judge Herndon has found that Boehringer Ingelheim acted in bad faith by withholding or wrongfully destroying documents relevant to the cases
In December, Judge Herndon hit the company with sanctions of nearly $1 million for its failure to maintain and submit numerous records from employees who worked on Pradaxa development or marketing. The judge cast aspersions on some of the excuses the company gave, like claiming a Windows 7 Operating System update wiped an important hard drive, saying they challenged credulity. The company may face more fines over its actions and juries will be told to weigh the company’s bad faith during the litigation in their deliberations.
Late last month, Judge Herndon also unsealed and released a number of documents that the company had deemed confidential, saying Boehringer Ingelheim had failed to show why the documents should be sealed. The judge took away the confidential designation for 85 different documents, although a few he released in redacted form.
When the documents were unsealed it was revealed that the company had changed the conclusions on a recently released study. The documents appear to suggest that the company knew that some patients may need medical monitoring because of the risk of potential bleeding events.
That ran counter to a major marketing point of Pradaxa, which claims that, unlike its competitor warfarin, patients need no monitoring to use Pradaxa safely.
The documents suggest that the drug maker had clinical data showing that some patients metabolize Pradaxa differently than others and might need medical monitoring. However, the lack of a need for medical monitoring was one of the main selling points of the anticopagulant, which was marketed as superior to the decades-old blood thinner warfarin because it is easier to use.
The documents suggest that Boehringer Ingelheim employees were so concerned about the findings of a research paper written by a company clinical program director, Paul. A. Reilly, that some suggested that the public should never hear of such conclusions. That paper was ultimately published earlier this month in the Journal of the American College of Cardiology.
The exchanges suggest that executives and other researchers felt that the paper would undermine much of the Pradaxa marketing campaign. However, others within the company acknowledged that the data was something the public needed to know, but suggested that it had to be released in a “smart” way that did not threaten Pradaxa’s potential sales.
Pradaxa Bleeding Concerns
Pradadxa (dabigatran) is a relatively new anticoagulant therapy that was approved by the FDA in October 2010. It was the first member of a new class of medications that are promoted as superior alternatives to warfarin, also known by the brand name Coumadin, for stroke prevention. However, shortly after its introduction, Pradaxa began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events.
Warfarin, sold under the brand name Coumadin, has been the go-to anticoagulant for decades. While Pradaxa was promoted as easier to use, because it requires less monitoring by the doctor during treatment, concerns have emerged about the lack of an effective reversal agent to stop the blood thinning effects of the medication.
Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.
During the first full year the drug was on the market in the United States, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.
All of the claims pending throughout the federal court system involve similar allegations and the outcomes of the early bellwether trials may influence Pradaxa settlement negotiations in a number of other cases.