Bayer Reaches Multimillion-Dollar Settlement Over Blood-Clot Risks with Yaz and Yasmin Birth Control Pills

In a settlement announced late last month, Bayer Corp. will pay nearly $57 million to resolve allegations that its oral contraceptives Yaz, Yasmin and Ocella cause strokes and heart attacks.

The settlement fund would cover claims pending in a multidistrict litigation in Illinois federal court, and lawsuits in state courts in New Jersey, Pennsylvania, and California, Law360 reports.

A Philadelphia law firm announced the multimillion-dollar settlement fund. The According to the firm, the settlement will 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. Those payments, however, 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 manufactures 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 women over 35 not to take combination oral contraceptives because of increased risk of serious cardiovascular events, including blood clots. Bayer agreed in March 2013 to a $24 million settlement for women who claimed they developed gallbladder disease or had their gallbladders removed after using Yaz and Yasmin birth control pills, according to court documents.

The side effects of drospirenone may include pulmonary embolisms, deep vein thrombosis (DVT), blood clots, heart attacks, strokes, damaged kidneys, damaged gallbladder, abnormal heartbeat, and death. Drospirenone acts as a diuretic and may cause elevated levels of potassium in the blood. Elevated potassium (hyperkalemia) can disrupt heart rhythms and slow blood flow throughout the body. Symptoms of hyperkalemia include nausea, fatigue, muscle weakness or tingling sensations.

Although Bayer agreed to the settlement, 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.” Bayer has been involved in litigation over drospirenone-containing oral contraceptives for more than six years, according to Law360.

A bellwether case that would have been the first to go to trial anywhere 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.

 

 

 

 

 

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