Pradaxa is a blood thinner (anticoagulant) medication that was sold without an approved antidote for at least five years, leading to severe bleeding and death in many people who took the drug. As a result, Boehringer Ingelheim – the manufacturer of Pradaxa – has faced thousands of lawsuits from patients, who filed personal injury and product liability claims against the pharmaceutical company.
Can I File a Pradaxa Lawsuit?
Although thousands of Pradaxa lawsuits were resolved as part of a settlement announced in 2014, individuals who have been negatively affected by the drug since then may be able to file a complaint based on their pain and suffering and additional medical expenses incurred because of the drug’s adverse effects.
If you have experienced severe bleeding, or if a loved one has passed away, after taking Pradaxa, the first step is to talk with an experienced lawyer who can review your case for free.
In May 2014, Boehringer Ingelheim announced that it had reached a comprehensive settlement of all the Pradaxa lawsuits then filed against the company in the United States. According to the company’s press release, the $650 million settlement would resolve approximately 4,000 outstanding claims against the pharmaceutical manufacturer.
Pradaxa Qualified Settlement Fund
As part of the master settlement agreement, a Qualified Settlement Fund was created. Plaintiffs who accepted the terms of the Pradaxa settlement would receive compensation from this fund to cover the costs of their medical expenses, pain and suffering, and related costs.
A small portion of the settlement fund (6% total) was also set aside to pay fees for lawyers and administrative expenses – known as “common benefits costs” – related to the lawsuits.
Pradaxa Settlement Fund Breakdown
|Payments to Plaintiffs||Attorney Fees||Common Benefit Costs|
Pradaxa Lawsuit Claims
Lawsuits filed by those who took Pradaxa (or their surviving family members) have made a number of legal claims against the Boehringer US.
Pradaxa as a Defective Drug
One of the most common claims is that because the anticoagulant did not have a reliable antidote for the first five years it was on the market, Pradaxa was an “unreasonably dangerous” drug. Despite the limitations of the drug and the lack of an antidote, Boehringer continued to market the drug without informing the public about alternative medications that were safer or equally effective alternatives they could choose.
The effect of Pradaxa being a defective drug, complainants argue, is that it could cause injuries that should have been foreseeable, had the company properly informed consumers of the drug’s potential harmful effects. Plaintiffs further allege that the benefits of the drug were outweighed by the risks of using it.
Failure to Inform
Coinciding with the dangerous nature of Pradaxa as a blood thinner with no antidote, plaintiffs have also argued that Boehringer had a duty to inform patients about the potential dangers of the drug. The pharmaceutical company had relevant information from clinical trials and other data that it could have used to better inform patients (or their physicians) before taking the drug, but instead the company chose to withhold that information.
Part of the failure to inform includes the company’s duty to inform the public about the dangers of Pradaxa. In most cases this is accomplished through the use of a warning on the drug label, but Boehringer US did not include such warnings about the relative risks of their medication. The blood thinner Xarelto faces similar lawsuits over complaints of inadequate warnings and no available antidote.
Harmful Effects Requiring Additional Care
Another common lawsuit claim is that Pradaxa side effects have led to the need for individuals to receive additional health care services and treatments that they otherwise would not have needed. This additional care led to expenses that should never have been incurred in the first place, not to mention pain and suffering caused by the defective drug.
Some of the additional expenses that could be caused by severe bleeding of Pradaxa include extended stays in the hospital, additional prescriptions to treat the effects of the drug, and any other long-term issues that may arise from using the drug.
Many lawsuits against Boehringer include a claim that the pharmaceutical company owed the general public – and the claimants specifically – a certain level of care when developing, studying, and manufacturing Pradaxa. By designing a drug that can cause serious harm and even death in patients who take it, the argument goes, Boehringer US neglected that duty.
Another way that Boehringer US neglected its duty according to Pradaxa lawsuits is by failing to include proper or accurate warnings on the drug’s label, notifying doctors and patients of the potential harms of the drug. Similar claims of negligence over “misbranding” and failure to comply with labeling regulations have also been a part of plaintiffs’ complaints.
Multidistrict Litigation – MDL 2385
The earliest Pradaxa lawsuits were filed separately in various states throughout the U.S. However, in August 2012, the U.S. Judicial Panel on Multidistrict Litigation decided to transfer 21 separate legal actions to the Southern District of Illinois, thereby centralizing administrative duties and making the process more efficient.
According to court records, more than 2,600 cases were transferred to MDL 2385 during the period in which the MDL was most active. The vast majority of these cases were resolved as part of the $650 million settlement described above.