More than 2,000 plaintiffs are now part of the Pradaxa multidistrict litigation (MDL) that formed just over a year ago. Plaintiffs in this MDL claim that Pradaxa’s manufacturer, Boehringer Inhelheim International, misled patients about the true risks of severe bleeding and other injuries related to the drug. Our team of Pradaxa attorneys will continue to update readers as the MDL moves forward.
Pradaxa is a popular blood thinner originally touted as a replacement to warfarin, which has been the most commonly prescribed blood thinner used for about six decades. The drug was approved in 2010 and was an instant blockbuster, earning Boehringer over $1 billion in sales. Just a few months after its approval, however, more than 300 patients reported serious bleeding complications after taking the drug, many of which resulted in wrongful death.
Boehringer Behaving Badly
When the MDL was approved, there were just over 20 injury lawsuits pending against Pradaxa’s manufacturer. Today, as stated, there are over 2,000. In December 2012, just four months after MDL approval, the judge slapped Boehringer with a $1 million penalty for failing to produce thousands of documents related to the trial. According to the complaint, Boehringer acted in bad faith in destroying the relevant documents, which could have had immense impact on plaintiffs’ arguments.
One week after the penalty was issued the judge ruled that Boehinger may be even more severely punished for its bad faith throughout trial. Meaning, should the issue arise in court the jury will be informed of Boehringer’s misconduct. The company may also be subject to additional fines, or may be banned from making specific arguments during trial.
Specifically, Boehringer destroyed or otherwise failed to preserve documents related to its former executive Thorstein Lehr, including smartphone and computer relevant to court proceedings. Lehr was a top-level scientist for Boehringer who specifically worked on Pradaxa research products.
In addition to Lehr’s data, Boehringer also destroyed evidence from a number of its sales representatives, medical liaisons, and clinical science consultants. Much of this information was contained on Boehringer’s shared network, “G Drive,” which the company claimed was plagued by production issues.
The Trouble with Pradaxa
Overall, bleeding events associated with Pradaxa use are not any more prevalent than those associated with warfarin. The problem lies in the complete lack of remedy for Pradaxa patients. Those prescribed to warfarin who suffer any incident of bleeding can be easily treated with Vitamin K, or a number of other easily-accessible remedies. In Pradaxa patients, however, there is no known treatment to stop bleeding.
In other words, if a patient with atrial fibrillation is prescribed Pradaxa to thin the blood, and that patient suffers even a minor accident -such as a fall or cut – that patients could bleed to death on hospital tables while doctors watch, helplessly. This exact incident has occurred more times than we know. Doctors throughout the country report scenes of minor injuries leading to catastrophic death because the patient was unable to stop bleeding from Pradaxa.
Thus, even if bleeding events do not take place more commonly in Pradaxa patients (compared to warfarin), the consequences are much more severe. The FDA has added several updates to Pradaxa’s labels concerning the risk of stroke and fatal bleeding events, however the agency refuses to imitate a recall.
The Pradaxa MDL is currently ongoing and many are predicting it will rank among the larger mass torts in U.S. history.