Florida plaintiffs Arminda Janousek and James Janousek have filed a Yaz lawsuit against Bayer Healthcare Pharmaceuticals Inc. after its birth control medications allegedly caused Arminda to suffer a severe blood clot injury.
Yaz, Yasmin, Ocella, Gianvi, and Zarah are birth control pills manufactured and marketed by Bayer. They are a combination of oral contraceptives that include both an estrogen (ethinyl estradiol) and progestin (drospirenone) component that work together to suppress ovulation, fertilization, and egg implantation. Yaz and Yasmin are Bayer’s premier birth control pills, while Gianvi and Ocella are recently developed generic versions of the drug distributed by other companies.
Drospirenone is a fourth-generation progestin and was first used in 2001. Yasmin was the first oral contraceptive to use the hormone. Because drospireneone is a relatively new hormone, there is currently not much scientific data available about the risks associated with it. This uncertainty about the hormone’s potential risks has led to criticism from doctors and the public.
Janousek’s Yaz birth control lawsuit alleges she continues to suffer from injuries caused by taking the medication. The Yaz lawsuit alleges that Bayer “failed to include adequate warnings that would alert the medical, pharmaceutical and scientific communities, users and consumers of the drugs, including plaintiff, of the potential risks and serious side effects of the drugs, including, but limited to, all possible adverse side effects as well as the symptoms, scope and severity of such side effects.”
The Yaz blood clot injury lawsuit asserts that because of a lack warnings and improper advertising, consumers were not able to make informed decisions when selecting oral contraceptives. Despite documented problems with the birth control pills, the plaintiffs allege Bayer continued to promote them. In response to marketing efforts by Bayer, the U.S. Food and Drug Administration released the following statement: “FDA is not aware of substantial evidence of substantial clinical experience demonstrating that Yasmin is superior to other COCs (combined oral contraceptives) or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone.”
The FDA’s warning also noted that Bayer’s promotional advertisements failed “to communicate that the potential to increase potassium is a risk” or that “increased serum potassium can be dangerous.”
This Yaz lawsuit is Arminda Janousek and James Janousek v. Bayer Healthcare Pharmaceuticals Inc., Case No. 3:14-cv-10320-DRH-PMF, in the U.S. District Court for the Southern District of Illinois.
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