Settlements In US Regarding Pradaxa Drug Concerns

Boehringer Ingelheim Confirms Plans To Settle Around 4,000 Cases


German drug manufacturer Boehringer Ingelheim has announced it is settling around 4,000 cases related to the blood-thinning drug Pradaxa (dabigatran), which has been linked to uncontrollable and sometimes fatal bleeding.

While the company has continued to deny any wrongdoing caused by the drug, it has confirmed it will be aiming to resolve the claims currently in the federal and state court system.

Approved in October 2010 in the US, the drug is generally used as a treatment to prevent blood clotting. However, concerns were raised following reports that the product had in some cases caused severe or fatal bleeding in patients.

In a statement issued to confirm the settlements, Andreas Neumann, head of the legal department and general counsel at Boehringer Ingelheim worldwide, said the firm remains “resolutely behind” Pradaxa.

He added the settlement would allow the company to “avoid the distraction” of legal action across a number of years.

In the UK, Pradaxa is licensed as an anticoagulant drug in the prevention of deep vein thrombosis (DVT) in people who have had hip or knee replacement surgery. It is also used in the prevention of stroke in people who are considered to be at high risk of having one. The recommended dose of Pradaxa varies, depending on the reason for requiring prescription.

In July 2012 the MHRA published a Drug Safety Update, highlighting additional circumstances where Pradaxa should not be used. This included that the drug should not be used in clinical conditions where the patient is at significant risk of major bleeding, as well as not being used with dronedarone or with the use of other anticoagulant agents. Exceptions to the latter would be when switching therapy to or from dabigatran, or with the use of unfractionated heparin for maintenance of venous or arterial catheter patency.

It added that renal function should be assessed in all patients before starting dabigatran and at least once a year in patients older than 75 years or those with a suspected decline in renal function. This is because exposure to dabigatran is substantially increased in patients with renal insufficiency.

Patients using Pradaxa may experience bleeding from the gums, frequent nose bleeds, heavy menstruation, bruising and blood in urine. If a patient using Pradaxa experiences any of these symptoms or coughs or vomits blood, they should seek medical advice immediately.

Expert Opinion
The settlement in these cases, albeit without an admission of liability, will be very welcome to patients who believe they have suffered as a result of this drug.

"Very serious concerns have been raised regarding the use of Pradaxa in the US and UK, and, as the drug is used widely across the world, a huge number of people will be keen for further reassurances regarding its safety.

"Given the severe bleeding that can be caused from use of Pradaxa, further clarification on how to reduce the risk of this occurring should not have been made evident years after the drug had been introduced to the market. As a result of this, a large number of people have been harmed from this drug, without warning.

"It is vital that the manufacturer, authorities and regulators work to allay any fears regarding the drug by providing clear information on when the drug should be used. It is equally important that anyone who believes they have suffered as a result of using the product seeks advice and support as soon as possible. Again, we find ourselves appealing to manufacturers and the authorities to ensure patient safety is of paramount importance."
Kevin Timms, Solicitor