Bayer, the manufacturer of Yasmin and Yaz birth control, is slowly moving in the right direction by strengthening its warning about blood clots. There is no plan to update the warning with respect to gallbladder injuries. Plaintiffs’ lawyers in the Yaz/Yasmin lawsuits contend that the progestin contained in the pills, drospirenone, is causing serious health problems in otherwise healthy women, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease.
The FDA informed Bayer in a letter earlier this month that it is responsible for updating its warning on a key issue in the Yaz lawsuits: whether Yaz causes blood clots. Still, Bayer is not putting a warning on Yaz/Yasmin that is going to clear its duty-to-warn obligation in future blood clots cases (and, again, this warning has no impact on the Yaz gallbladder cases). The new Yaz/Yasmin labels make clear Bayer is not backing all the way down: “The serious side effects of the pill occur very infrequently, especially if you are in good health and are young.”
Bayer is in an interesting spot with Yaz/Yasmin. These birth control drugs combined were Bayer’s most profitable drug last year. Yaz and Yasmin are also Bayer’s biggest seller and the leading birth control pill in North America. I strongly suspect Bayer realizes a strong warning means less prescribing doctors which means less profits. But if Bayer ignores the growing evidence that Yaz and Yasmin are more dangerous than other comparable birth control pills, they are risking lawsuit payouts that exceed the generous profits they now enjoy. Nothing short of a Yaz recall is going to stop the flow of future lawsuits.