April 16, 2012 — Bayer has agreed to pay at least $110 million to settle about 500 lawsuits alleging that its contraceptives Yaz and Yasmin caused blood clots that led to injury or death, according to people familiar with the settlement, Bloomberg Businessweek reports.
The Germany-based drugmaker since 2009 has faced claims that it misled women about the risk of blood clots. The settlement comes in the first case scheduled for trial of more than 11,000 such lawsuits. Lawyers for the plaintiffs said that FDA reports have linked at least 50 deaths to the pills between 2004 and 2008.
Bloomberg Businessweek reports that the settlement was a result of mediation. Last year, U.S. District Judge David Herndon, who was handling the first consolidated cases, recommended that a mediator look into the possibility of a settlement. Carl Tobias, a professor of product-liability law at the University of Richmond, noted that mediation is often a "less expensive way to deal with these kinds of cases."
According to data from IMS health, Bayer's Yasmin was the fourth most popular contraceptive in 2011, with 4.6% of the market as of September. In 2010, Bayer's contraceptives generated $1.58 billion in sales.
The settlement comes after FDA on April 10 ordered Bayer and other manufacturers of birth control pills containing the hormone drospirenone to strengthen the blood clot warnings on their products. The labels must now state that research has shown that drospirenone birth control pills might increase the risk of blood clots by up to three times more than other contraceptives (Feeley/Cronin Fisk, Bloomberg Businessweek, 4/13).