A settlement reported to run to nearly $57 million would resolve allegations that Bayer Corp.’s birth control pills Yaz, Yasmin, and Ocella cause strokes and heart attacks.
The settlement announced in late July would settle claims pending in a multidistrict litigation in Illinois federal court, and suits in Pennsylvania, New Jersey and California state courts, Law360 reports.
A law firm in Philadelphia announced the settlement and 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.” According to the law firm, Bayer has already paid close to $2 billion to resolve claims over venous blood clots, including pulmonary embolisms and deep vein thrombosis, but the company still faced claims over injuries from arterial blood clots until this settlement was reached. Law360 reports that the settlement fund will cover about 1,200 cases nationwide.
Bayer produces four oral contraceptives containing drospirenone—Yasmin, Yaz, Beyaz and Safyral. Results from an FDA-funded study suggest there is approximately a 1.5-fold increase in the risk of blood clots in women who use birth control pills containing drospirenone compared to women who take 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.
Drospirenone is a diuretic that may elevate the levels of potassium in the blood stream. Elevated levels of potassium in the blood stream (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. Drospirenone side effects may include pulmonary embolisms, deep vein thrombosis (DVT), blood clots, heart attacks, strokes, damaged kidneys, damaged gallbladder, abnormal heartbeat, and death.
Although a company statement said Bayer does not believe these drugs create increased risk of arterial blood clots, the company agreed to the settlement “in order to avoid the cost and distraction of litigation,” according to company vice president Steven Immergut. Litigation involving Bayer’s drospirenone-containing oral contraceptives has lasted for more than six years, Law360 reports.
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 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.
In addition to blood-clot claims, Law360 reports that court documents indicate that in March 2013, Bayer agreed to pay $24 million to patients who developed gallbladder disease or had their gallbladders removed after using Yaz and Yasmin birth control pills.