German drugmaker Bayer AG is set to pay more than $100 million to settle hundreds of lawsuits brought by women alleging that its Yasmin birth control pills cause dangerous blood clots. Several Yasmin-related blood clots have caused fatal strokes and heart attacks. At least 50 Yaz-related deaths were reported to the Food and Drug Administration between 2004 and 2008. Safety regulators also allege that the drugmaker marketed its Yaz birth control pills for unapproved off-label uses.
Individuals familiar with this pharmaceutical product liability litigation told Bloomberg News that a large settlement is likely after an Illinois judge postponed a January trial date in favor of a mediated settlement. A Bayer spokeswoman confirmed that some of the product liability cases against Bayer were being settled, but declined to comment on the number of cases or the amount of any potential settlement.
“Sounds to me like mediation is paying off,” a product liability law professor said. “As a German company, Bayer probably would like to avoid the risks and costs of litigation in U.S. courts. Mediation tends to be a less expensive way to deal with these kinds of cases.”
Bayer AG brought in $1.58 billion in sales from its contraceptives in 2010, making them the company’s second biggest revenue-generating drugs and the fourth most used oral contraceptive in the U.S.
According to recent U.S. Securities and Exchange Commission filings, at least 70 Yaz cases have been settled by Bayer already.
“Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis,” Bayer wrote in its SEC filings.
The company’s American Yaz website now includes strong warnings about the risks of blood clots, stroke and heart attack. These risks increase in women who have kidney, liver or adrenal disease and smokers over the age of 35.
Source: Business Week, “Bayer Said to Pay $110 Million in Yaz Birth Control Cases,” Jef Feeley, April 13, 2012