Pharmaceutical Business review

Bayer, Janssen settle litigation over blood thinner Xarelto

Image: Headquarters of Bayer’s pharmaceuticals division in Berlin, Germany. Photo: courtesy of Bayer AG.

The companies have reached settlement more than five years after the litigation started with Xarelto. During the period, all six cases related to Xarelto went to trial.

Bayer noted that the settlement amount will be shared equally between the two companies and its share is expected to be partially offset by product liability insurance.

The settlement will help solve virtually around 25,000 Xarelto claims in the US. The companies have also flexibility to withdraw from the settlement if certain participation rates of those who are eligible to participate are not satisfied

Bayer also said that it continues to believe these claims are without merit and there is no admission of liability under the agreement.

The favorable settlement enables Bayer to avoid the distraction and significant cost of continued litigation.

Xarelto is a prescription medicine used to decrease the risk of stroke and blood clots in patients with atrial fibrillation, which is not caused by a heart valve problem.

Xarelto can also be used for the treatment of blood clots in the veins of legs or condition called deep vein thrombosis (DVT), as well as veins in lungs or condition known as pulmonary embolism (PE).

The treatment can also be used to prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

Xarelto, in combination with low dose aspirin, will also helpful in reducing the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease.

Bayer further said the safety profile of Xarelto remains positive and unchanged as confirmed time and again by regulatory agencies across the world.

In addition, premature discontinuation of any oral anticoagulant, including Xarelto, will increase the risk of thrombotic events. Active pathological bleeding and severe hypersensitivity reaction are the major contradictions with Xarelto.