Watson Likely to Face Lawsuits Over Generic Yasmin, Marketed as Zarah

Bayer Healthcare has indicated that they are going to move forward with a patent infringement lawsuit against Watson Pharmaceuticals Inc. over its introduction of Zarah, a generic version of Yasmin birth control. In addition, as women start using the new generic Yasmin, it is likely that Watson will also find itself the target of product liability lawsuits over the increased risk of blood clots and other injuries that have been associated with side effects of Yasmin. 

Earlier this week, the FDA granted Watson approval for an Abbreviated New Drug Application (ANDA) for Zarah, which is the generic equivalent of Yasmin. Bayer attempted to prevent Watson from filing the request, but a court denied their motion last week. The drug maker now indicates that they will continue with their litigation over generic Yasmin, seeking monetary damages for Watson’s alleged patent infringement.

Bayer is currently involved in similar litigation over generic Yaz birth control, which is a lower dose version of the Yasmin birth control pill. Earlier this summer, Teva Pharmaceuticals introduced Gianvi, a generic version of Yaz, which Bayer alleges violated an agreement between the two companies, as well as patent protections that should have prevented the introduction of a generic Yaz until 2014.

Yaz and Yasmin both contain a new “fourth generation” progestin, known as drospirenone, which is unique to these birth control pills and their generic equivalents. However, drospirenone has been cited as the likely cause of an increased risk of health problems from Yaz and Yasmin, such as strokes, heart attacks, pulmonary embolism, deep vein thrombosis, gallbladder disease and other potentially life-threatening injuries.

Thousands of women have already filed lawsuits over Yaz and lawsuits over Yasmin alleging that Bayer failed to provide adequate warnings about the risks associated with the birth control pills. Since the label for Watson’s generic Yasmin will contain the same warnings as the name brand medication, the generic drug maker is likely to see a number of Zarah lawsuits filed if otherwise healthy women suffer injuries due to the inadequate warnings.

All federal Yasmin and Yaz litigation has been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), under Chief Judge David Herndon in the U.S. District Court for the Southern District of Illinois. It is likely that the generic Yasmin lawsuits would also be centralized as part of the same MDL.