After taking a $500 million charge against 2012 earnings for Yaz and Yasmin-related litigation, Bayer has lost its patent fight with three generics makers intent on selling their own copycats.
French regulators are tightening the purse strings on later-generation contraceptives--and studying limits on their use. Acting on concerns that the pills carry a higher risk of blood clots than older birth-control brands, the country's health ministry will stop paying for third-generation pills beginning March 31.
Bayer, already one of the biggest players in the $8 billion a year contraceptive drug market, is aiming to take on Johnson & Johnson ($JNJ) in Europe with a transparent birth control patch.
That €500 million ($615.8 million) that Bayer set aside to cover its Yaz and Yasmin litigation? A big chunk of it is already spent. The company said it has settled almost 1,900 lawsuits for a total of $402 million-plus. That's an average of about $212,000 per case.
Bayer set aside $500 million to cover litigation over the Yaz and Yasmin birth control pills, after FDA added blood-clot warnings to their labels in April.
Three months of negotiations have apparently resulted in Bayer deciding that claims against its Yasmin line of birth control are worth about $220,000 each.
To make sure doctors and patients are aware of the potential dangers, the pills' labels will now include study data suggesting as much as a threefold increase in clotting risk.
Plaintiffs in the Yaz and Yasmin litigation are asking U.S. District Judge David Herndon to check out evidence of possible conflicts-of-interest on an FDA advisory panel that considered the pills'
The first Yaz trial won't open as scheduled. A federal judge delayed the bellwether patient lawsuit, set for trial next week, and appointed a special master to mediate instead. And this special
Bayer 's profit margins are dropping as a result of the European debt crisis. The German drug giant is responding as any cautious drug company would--by stocking up on cash, Reuters is reporting.