According to a report in Bloomberg News, Bayer AG will pay at least $110 million to settle about 500 lawsuits over claims that its Yaz, Yasmin, Ocella lines of birth-control pills caused blood clots, in the first round of case settlement.
Bayer, is based in Leverkusen, Germany, and agreed to pay an average of about $220,000 a case to resolve the claims that its Yaz, Yasmin, Ocella drugs caused venous thrombo-embolism that can lead to heart attacks, deep vein thrombosis, pulmonary embolism and strokes.
The settlements came after federal judge Herndon overseeing the MDL litigation in Illinois postponed Jan. 9 bellwether trials. The complaints alleged that Bayer and some of its units mislead women about the health risks of its birth-control pills.
Stronger FDA Label Change and Warnings
The settlements come as the U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen the blood-clot warnings on their products.
Bayer’s Yaz, Yasmin and Ocella, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.
Prior Bayer Settlements
Bayer officials said in a Feb. 28 U.S. Securities and Exchange Commission filing that the drugmaker has settled 70 cases over the Yasmin line of contraceptives.
Those settlements included “terms and conditions which Bayer views to be reasonable,” officials said in the filing. “Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.”
In 2011, the U.S. FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives.
The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.
The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).