Yaz Lawsuit Filed in California Superior Court
Two women filed a Yaz lawsuit against Bayer and other defendants in the California Superior Court in San Francisco County on April 5, 2013. The plaintiffs allege serious, long-term injuries after they used Yaz, Yasmin, and/or Ocella oral contraceptives. According to the legal complaint, Bayer allegedly designed and manufactured defective birth control pills that directly caused the plaintiffs to incur economic and non-economic losses. The plaintiffs are seeking compensatory and punitive damages.
Yasmin and Yaz blood clot risk
Yasmin and Yaz are oral contraceptives that contain a progestin named drospirenone and an estrogen called ethinyl estradiol. Yaz is comprised of 3 mg of drospirenone and .02 mg of ethinyl estradiol while Yasmin contains 3 mg of drospirenone and .03 mg of ethinyl estradiol. Oral contraceptives manufactured by competitors used progestins such as levonorgestrel, desogestrel, and gestodene, which were subjected to years of clinical studies. Prior to Yasmin receiving FDA clearance in 2001, drospirenone was never marketed in the U.S.
Even though Yasmin and Yaz were advertised as a safe and effective way to prevent pregnancy, the FDA has received hundreds of adverse event reports regarding the oral contraceptives. According to the results from medical studies, the combination of drospirenone with estrogen heightened the Yaz blood clot risk. Consumers who used Yaz, Yasmin, and Ocella were also at risk of developing stroke, heart attack, organ failure, and other injuries. From 2004 through 2008, there were 50 reports of death among women who used the oral contraceptives. Based on the FDA’s review of several epidemiologic studies, it determined that birth control pills with drospirenone may be linked to a higher risk of blood clots.
FDA warnings regarding Yaz and Yasmin
According to the Yaz lawsuit, Bayer misrepresented and intentionally concealed material information regarding Yaz and Yasmin in their advertising materials. The manufacturer received FDA warnings regarding Yaz and Yasmin for misleading the public by overstating the benefits of the birth control pills while failing to fully disclose the side effects. On July 10, 2003, the FDA issued a warning letter advising there is no clinical evidence to support the claims that drospirenone in Yasmin was more beneficial than the progestins used in other oral contraceptives.
On October 3, 2008, the FDA sent another warning letter stating that Bayer could not promote the birth control pills as an effective treatment for off-label uses such as premenstrual syndrome, acne, anxiety, and irritability. Bayer spent at least $20 million correcting the misleading advertisements. Bayer is also required to have the FDA pre-screen their promotional materials for a period of six years.
Plaintiffs suffer pulmonary embolism after using Yaz
According to the recent lawsuit, the plaintiffs began to sustain severe injuries after using the birth control pills as directed. The plaintiffs allege that Yaz and Yasmin are defective medical products that directly caused them to suffer side effects such as pulmonary embolism, bodily impairment, and mental anguish. Both plaintiffs will continue to need medical treatment and healthcare services in the future.
Allegations raised in the complaint state that the plaintiffs’ injuries were caused by the negligence, fraudulent misrepresentation, and other wrongful acts of the defendants. Yaz and Yasmin are allegedly defective and Bayer failed to perform sufficient clinical safety trials before distributing the birth control pills to consumers. Bayer knew or should have known that using the birth control pills increased the risk of patients suffering from blood clots, deep vein thrombosis, strokes, heart attacks, and other life-threatening side effects from Yaz/Yasmin. The lawsuit states the oral contraceptives are unreasonably dangerous, but the defendants didn’t adequately warn about the defects and safety risks.
The plaintiffs demand a jury trial to resolve the legal issues raised in the Yaz lawsuit. They are demanding damages for past, present, and future medical expenses, loss of earnings, and reduced earning capacity. Like others involved in Yaz litigation, the claimants are also seeking compensation for pain and suffering, diminished quality of life, attorney fees, and legal costs.