Yaz, Yasmin and Ocella (Generic Yasmin) birth control have made billions of dollars for Bayer and Berlex, who have advertised the oral contraceptives not only for birth control, but also as a cure to acne and premenstrual problems. Tragically, thousands of young women have paid the ultimate price with lethal side effects ranging from blood clots to heart attack, gallbladder injuries and sudden cardiac death.
Tragically, thousands of young women have paid the ultimate price with lethal side effects
Medical experts believe that safety issues relating to blood clots may have surfaced as early as 2001 in the clinical trials for Yasmin. Recent evidence suggests that Berlex, the drug’s original manufacturer, and its successor, Bayer, knew as early as 2003 that users of Yasmin faced twice the risk of suffering blood clots as patients using competing products. Yet, the companies invested millions in advertising, including advertising deemed inappropriate by the FDA due to promotion for unapproved uses, while it utilized warnings similar to those used for safer birth control drugs in an effort to hide the unique safety risks of their products which contain the unique progestin, drospirenone.
Evidence suggests that Berlex and its successor, Bayer, knew as early as 2003 that users of Yasmin faced twice the risk of suffering blood clots as patients using competing products.
In addition to preventing pregnancy, Yaz, Yasmin, and Ocella are approved by the Food & Drug Administration (“FDA”) to treat moderate acne in women at least 14 years old, and also to alleviate severe symptoms of premenstrual dysphoric disorder (also known as PMDD), which includes anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, muscle or joint pain, headaches, and weight gain. However, the drug was never tested or approved by the FDA for the treatment of simple PMS symptoms. The advertising suggested that women who took Yaz and Yasmin would not bloat, be irritable or have skin problems. The FDA determined that the advertising was false and misleading.
The drug was never tested or approved by the FDA for the treatment of simple PMS symptoms.
Since 2003, the manufacturer of Yaz and Yasmin has received several warnings from the FDA about Bayer’s marketing of Yaz and their exaggeration of the drug’s treatment capabilities. The FDA has criticized Berlex and Bayer repeatedly for failing to warn consumers and for airing television ads that overstated efficacy, over-promised benefits, promoted the drugs for unapproved uses, and under-emphasized risks. Ultimately, the FDA forced Bayer to run a series of corrective commercials informing consumers that previous ads touting the use of Yaz for the prevention of PMS and associated symptoms were improper and illegal.
The FDA will also be conducting hearings in December of 2011 to review newer safety information that shows a two to five-fold increased risk of thromboembolic or blood clot-related injuries in women taking birth control medications that contain drospirenone, which generally provide no greater benefits than those noted with older, safer birth control pill formulations that utilize a different progestin.
Nearly 10,000 individual lawsuits have been filed involving women and girls who suffered blood clot-related injuries (including deep vein thrombosis (DVT), pulmonary embolus (PE), heart attack, stroke, or sudden cardiac death) or gallbladder injuries following their ingestion of Yaz, Yasmin, or Ocella. Litigation is pending in federal court in East St. Louis and Illinois, and in state courts in California, New Jersey and Pennsylvania. The first trials are expected to occur in the state and federal court system during the first half of 2012.
Brenda Fulmer is a shareholder at the law firm Searcy Denney Scarola Barnhart & Shipley in West Palm Beach and partners with Pasternack Tilker Ziegler Walsh Stanton & Romano in the litigation of drug and pharmaceutical mass tort cases. Ms. Fulmer graduated from the University of South Florida with a B.S. in Finance, and received her Juris Doctor degree cum laude from Stetson University College of Law. For the past 17 years, she has represented thousands of mass torts plaintiffs in both state and federal courts who have been injured by defective medical devices and drugs.
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