Bayer Corp. has agreed to a settlement of nearly $57 million over allegations that its birth control pills Yaz, Yasmin and Ocella caused strokes and heart attacks.
The proposed settlement, announced late last month, would settle claims pending as part of a multidistrict litigation program in Illinois federal court, as well as suits that have been filed in Pennsylvania, New Jersey and California state courts, Law360 reports.
The Philadelphia law firm that announced the settlement said the settlement would ensure that “those who allegedly suffered arterial blood clot injuries as a result of Yaz, Yasmin and Ocella are compensated fairly and efficiently.” The firm said Bayer has already paid close to $2 billion to resolve claims over venous blood clots, including pulmonary embolisms and deep vein thrombosis, but until this settlement was announced the company still faced numerous suits over injuries from arterial blood clots. The settlement fund will cover about 1,200 cases nationwide, according to Law360.
Bayer produces four drospirenone-containing birth control pills—Yasmin, Yaz, Beyaz and Safyral. Drospirenone side effects may include pulmonary embolisms, deep vein thrombosis or DVT, blood clots, heart attacks, strokes, damaged kidneys, damaged gallbladder, abnormal heartbeat, and even death. An FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives. The FDA advised women taking these contraceptives to seek immediate medical attention if they develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. Women over 35 should not take combination oral contraceptives because they increase the risk of serious cardiovascular events, including blood clots.
Bayer said in a statement that it had agreed to settle the cases despite its belief that the drugs did not carry an increased 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 and to put the focus back on what matters most—the needs of patients.” Litigation involving Bayer’s drospirenone-containing oral contraceptives has lasted for more than six years.
As the proposed settlement was reached, a bellwether case, which would have been the first to go to trial anywhere in the U.S., was scheduled for trial in November. The case involved claims filed in August 2009 by a woman who suffered a stroke after taking Yasmin. This was one of 350 claims pending in Philadelphia County as part of a mass tort program.
In March 2013, Bayer agreed to pay $24 million to patients claiming they developed gallbladder disease or had their gallbladders removed after using Yaz and Yasmin birth control pills, according to court documents. Law360 reports.