Multimillion-Dollar Settlement. A settlement reported to total nearly $57 million would resolve allegations that Bayer Corp.’s birth control pills Yaz, Yasmin and Ocella cause strokes and heart attacks. The settlement fund would settle claims pending in a multidistrict litigation in Illinois federal court, and suits in Pennsylvania, New Jersey and California state courts, Law360 reports.
The agreement was announced by a Philadelphia law firm. The firm said the settlement fund would ensure that “those who allegedly suffered arterial blood clot injuries as a result of Yaz, Yasmin and Ocella are compensated fairly and efficiently.”
Bayer has already paid close to $2 billion to resolve claims over venous blood clots, including pulmonary embolisms and deep vein thrombosis, but those payments did not resolve claims over injuries from arterial blood clots. The new settlement fund will cover about 1,200 cases across the country, Law360 reports.
Bayer produces four different birth control pill formulations
Bayer produces four different birth control pill formulations containing drospirenone-Yasmin, Yaz, Beyaz and Safyral. In 2012, after reviewing epidemiological studies of the risks of blood clots among women who take drospirenone-containing contraceptives, the Food and Drug Administration (FDA) ordered changes to the drug labels to include those risks.
The agency said estimates of the risks were not consistent across the studies, but results from a study the FDA funded suggested an approximately 1.5-fold increase in the risk of blood clots with use of drospirenone birth control pills compared to other hormonal contraceptives.
Women taking these oral contraceptives should immediately contact their doctor if they develop symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath, the FDA advises.
In addition, women over 35 should not take combination oral contraceptives because they increase the risk of serious cardiovascular events, including blood clots. In March 2013, Bayer agreed to pay $24 million to patients who claimed they developed gallbladder disease or had their gallbladders removed after using Yaz and Yasmin birth control pills, according to court documents.
Drospirenone side effects may include pulmonary embolisms, deep vein thrombosis (DVT), blood clots, heart attacks, strokes, damaged kidneys, damaged gallbladder, abnormal heartbeat, and death. Drospirenone, which acts as a diuretic, may cause elevated levels of potassium in the blood.
Elevated levels of potassium (hyperkalemia) can disrupt heart rhythms
Elevated levels of potassium (hyperkalemia) can disrupt heart rhythms and slow the flow of blood throughout the body. Symptoms of hyperkalemia include nausea, fatigue, muscle weakness or tingling sensations.
Bayer agreed to the settlement, although a company statement said Bayer does not believe the birth control pills increase the risk of arterial blood clots. Bayer vice president Steven Immergut said the company agreed to the settlement “in order to avoid the cost and distraction of litigation.”
According to Law360, Bayer has been involved in litigation over its drospirenone oral contraceptives for more than six years.
A bellwether case that would have been the first to go to trial in the U.S. was scheduled for trial in November. The case was filed in August 2009 by a woman who suffered a stroke after taking Yasmin. This case was one of 350 claims pending in Philadelphia County as part of a mass tort program.