The Trouble with the Pitch: Off Label Uses of Yaz and Yasmin

Birth control pills were originally developed to do exactly as it says: prevent unwanted pregnancies. The first oral contraceptives were not always effective even with perfect use, but newer formulations have proven to be highly efficacious. Of course, as is typical with most pharmaceutical solutions, there are side effects that range from uncomfortable to potentially fatal. It is accepted that with any type of oral contraceptives, there are common side effects such as blood clotting, gallbladder complications, and possible cardiac problems.

Currently, much attention has been brought to bear on the newest crop of oral contraceptives which contain drosperinone because it is suspected that the typical risks associated with oral contraceptives may be higher with 3rd and 4th generation progestins such as drosperinone than 1st and 2nd generation ones. Among the most targeted products in this category for product liability cases are Yaz and Yasmin, both manufactured by Bayer. The most popular allegation is that Bayer knew or should have known about these elevated risks and failed to give due warning to users. Bayer continues to deny these allegations as it steadily settles thousands of cases.

But to add salt to injury, Bayer had mounted an aggressive and highly successful direct-to-cutomer (DTC) marketing campaign which touted the success of Yaz and Yasmin for off label use such as treatment of premenstrual syndrome and severe acne before the Food and Drug Administration could put a stop to it. By then, doctors had prescribed the drugs to a lot of women who would otherwise not take oral contraceptives for treatment of these conditions, believing that they were no more harmful than older formulations.

As a result, more than 12,000 women or their representatives are now waiting for the outcome of litigation or settlement offers for injuries they sustained from the use of Yaz and Yasmin. By what percentage that number would have been reduced if Bayer had not encouraged the off-label use of the product is hard to determine, but it is probably a significant number.

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