Yaz and Yasmin lawsuits are still pending against Bayer, the manufacturer of the two drugs. In addition to failing to warn consumers of the drugs' dangerous side effects, Bayer must be held responsible for engaging in extensive off-label promotion of Yaz and Yasmin for unapproved uses.
Drugs are regulated by the FDA based on their intended conditions of use and may not be promoted or marketed for non-approved or 'off-label' uses. It is a drug's 'intended use' that is reviewed and approved by the FDA. Thus, it is not the chemical compound that is approved, but a chemical compound for a specific disease or condition at a specific dose that FDA reviews and approves. 'Off-label' uses are those that the FDA has not determined to be safe or effective, either because the manufacturer did not submit an application requesting approval for such uses, or because the FDA did not approve an application that was submitted in support of such uses.
FDA regulations prohibit drug manufactures from promoting drugs for non-approved uses. All major pharmaceutical manufactures are well aware of these provisions, which have been in force for decades. Nonetheless, Bayer promoted Yaz and Yasmin off-label for unapproved uses. In an effort to increase sales and profits, Bayer induced thousands of women to take these drugs. Increased sales and consumption caused thousands of women to suffer serious injuries and recklessly exposed thousands more to the drugs harmful side effects. Bayer must be held accountable for such flagrant behavior and thus liable for the damages inflicted on innocent women.
Yaz and Yasmin were both FDA approved for the specific indication of oral contraception. Yasmin was approved in May 2001 and has not received FDA approval for any other indication. Yaz was approved for oral contraception in March 2006. In October 2006, Yaz received subsequent approval to treat "Premenstrual Dysphoric Disorder" (PMDD) and approved for "moderate acne vulgaris" in January 2007.
With the approval of Yaz in 2006, Bayer began a huge marketing campaign promoting the two drugs. Despite the limited and specific indications for which Yaz and Yasmin were approved, Bayer's campaign promoted the drugs for 'Premenstrual Syndrome' (PMS), "severe PMS," relief of the physical and emotional symptoms associated with the menstrual cycle, acne and skin benefits.
Neither Yaz nor Yasmin was ever approved for PMS, severe PMS or for relief of the physical and emotional symptoms associated with the menstrual cycle. While Yaz was approved for "moderate acne vulgaris" it was neither approved for acne, nor for general benefit to skin condition. Bayer's extensive off-label promotion of Yaz and Yasmin for these unapproved uses is a clear violation of FDA regulations.
Bayer's marketing campaign not only persuaded thousands of women to take these drugs but also misrepresented and omitted the dangers of blood clots, pulmonary embolisms and other serious side effects. Bayer's actions violate FDA regulations, are contrary to good industry practice, and place all consumers at serious risk. Bayer must be held responsible for such flagrant behavior and liable for the damages Yaz and Yasmin inflicted on innocent women.
Bayer, not the FDA, is primarily responsible for the safety of its products. Bayer and all drug manufacturers have the responsibility to study a drug for its intended uses and submit such data to the FDA for their approval before they may promote and market a drug for non-intended uses.
The attorneys at JONES WARD PLC represent women from all over the country who have suffered blood clots, deep vein thrombosis, pulmonary embolisms, strokes and other serious side effects after taking Yaz, Yasmin and Ocella. If you or someone you know has suffered any of these side effects because of these drugs, contact attorney Terrance Massey at JONES WARD PLC.