Sometimes it takes a mainstream media news report to bring out the response of a drug maker. In this case, Germany’s Boehringer Ingelheim says the mounting number of lawsuits filed over the drug Pradaxa are, “without merit,” and it plans to fight each and every one of them.
That will keep the company very busy as the number of people injured by this new blood thinner is likely to run into the thousands.
The latest study on warfarin (Coumadin) and dabigatran (Pradaxa) released at the Thrombosis and Hemostatis Summit of North America, reports complications associated with Pradaxa use occur mostly early on in treatment with most occurring on average after less than four months of therapy.
Boehringer says it “acted appropriately and responsibly,” in the development of Pradaxa and believes the medication has more benefits than risks. With about $1.48 billion in sales, company officials have a lot of reasons to sing its praises.
Product liability lawsuits will try to uncover what Boehringer knew and when did it know it. Did the company knowingly sell a drug it knew would put people at risk for fatalities? How could it not? Boehringer has said it is working on an antidote to stop the bleeding. The old standby blood thinner warfarin (Coumadin) can be reversed by giving a bleeding person vitamin K. Not so with Pradaxa, so how could the company not have known Pradaxa was a defective and unsafe product?
The Institute of Safe Medication Practices, a nonprofit that monitors drug safety, reports Pradaxa is at the top of the list of more than 800 medication complaints the group monitors.
Predictions are there will be upward of 4,000 lawsuits filed while Pradaxa remains on the market. The only warning is contained in its product insert. That expresses concerns patients older than 74 or those with kidney problems might be a greater risk of uncontrolled bleeding while taking Pradaxa.
Because the drugmaker is not U.S. based, a product liability law professor at the University of Richmond in Virginia tells Bloomberg that a global settlement is more likely to resolve claims, largely because an international drug company is not as familiar or comfortable with the U.S. courts and a product liability lawsuit.