Lawsuits filed by plaintiffs alleged that the pills caused blood clots, gallbladder issues, heart attacks, and strokes. Lawsuits also alleged that Bayer knew or should have known of the alleged risks and failed to disclose them or adequately warn the users, fraudulent concealment, negligence, and many more. They also accuse Bayer of not doing enough research and failing to issue a recall after reports showed risks.
Women who suffered from side effects after taking Yaz and related pill Yasmin, both for birth control filed more than 17,000 lawsuits against Bayer. The cases filed in Pennsylvania, New Jersey, and California state courts were centralized in Illinois federal court.
At its height, more than 17,000 files with multiple plaintiffs per file had been brought in four jurisdictions, making it the largest multi-district litigation in the nation.
Yaz, Yasmin, and Ocella birth control lawsuits filed against Bayer were consolidated in 2009 into a mass tort program in Pennsylvania, a federal multidistrict litigation (In re: MDL 2100 - Yasmin and YAZ (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, presided by U.S. District Judge David R. Herndon), and consolidated litigations in New Jersey and California.
Bellwether trials in Philadelphia and in the MDL that were gearing up in 2012, stayed as Bayer began to settle thousands of blood clot claims involving pulmonary embolisms, deep vein thrombosis and/or gallbladder injury. Only 360 cases remained pending in the Philadelphia Complex Litigation Center.
On August 6, 2015, Bayer announced to set aside almost $57 million as settlement amount to resolve arterial blood clot claims including heart attack and stroke without admission of wrongdoing or liability.
Jul 29, 2019: Lack Of Potency Led To Generic Yaz Birth Control Pill Recall: On July 23, 2019 FDA announced a recall on generic Yaz (drospirenone and Ethinyl estradiol) birth control pills sold by Jubilant Cadista Pharmaceuticals Inc. due to the risk of ineffective birth control, which may lead to unwanted pregnancies, even when taken as directed.
According to the notice, the pills were ineffective as the absorption of the active ingredients was decreased, which left women with inadequate protection against becoming pregnant.
Ethinyl estradiol and drospirenone tablet is a generic estrogen/progestin combination oral contraceptive, widely used by women to treat symptoms of the premenstrual dysphoric disorder, prevent pregnancy, and treat moderate acne.
The recall affected one lot of the generic Yaz pills distributed across the United States. It contains 3mg/0.01 mg packed in a carton with 3 blister cards, each card contains 28 film-coated, biconvex tablets with 24 round active pink tablets, and four inert while colored tablets. Lot number 183222 with NDC number 59746-763-43 and expiration date of 11/2020 was affected by the recall. The company stated that they are notifying customers by email and sending a recall notification letter and response forms to return the product.
Yaz lawsuits were consolidated under MDL No. 2100, presided by Judge David R. Herndon in the Southern District of Illinois. As of January 2019, no cases are pending in the MDL.
Jun 19, 2018: Bayer Denies Claim Made By Plaintiff In A Related Yaz Case: A New Jersey State Appeals Court found loopholes in the expert report of a woman who blamed Bayer AG's Yaz and Yasmin birth control pills for her gallbladder disease. The pharmaceutical giant denied the claim made by the plaintiff to restore the litigation.
The lawsuits concerning Yaz-related pulmonary embolism were the first to go for a state court trial, followed by gallbladder injury cases and the final round would include blood clot injuries.
By May 2014, Bayer settled more than 8,200 lawsuits over pulmonary embolisms, heart attack, and deep vein thrombosis (DVT), spending nearly $1.7 billion. As of May 2018, 63 Yaz and Yasmin lawsuits are pending in the multidistrict litigation (MDL No. 2100; In Re: Yasmin and Yaz Marketing, Sales Practices and Products Liability Litigation), which was formed in 2009 and is presided by Judge David R. Herndon in the Southern District of Illinois.