Yasmin/Yaz Litigation

Television Advertisements

Bayer Healthcare Pharmaceuticals, Inc. (Bayer) has repeatedly come under fire by the U.S. Food and Drug Administration (FDA) for misleading advertisements of its Yaz and Yasmin birth control pills. The first warning came in October of 2008, when the FDA cited the pharmaceutical giant for overstating the effectiveness of Yaz, misrepresenting its intended use, and minimizing the risks. Two 60-second television commercials, titled “Balloons” and “Not Gonna Take It” were the advertisements in question. Both asserted that Yaz was different from other forms of birth control pills and implied that Yaz could completely eliminate the symptoms associated with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and acne – assertions not entirely supported by clinical evidence.  This information has sparked Yaz lawsuits across the country.

If you believe you were injured by taking Yaz or Yasmin, call our law firm to speak with one of our attorneys today to speak about Yaz!

In the lengthy and descriptive letter to Bayer, the FDA insisted that the design of the ads was confusing to consumers in that it blurred the lines between PMDD and PMS. While PMDD and PMS share similar symptoms, they are not the same condition. Furthermore, Yaz is not even approved to treat PMS and both commercials failed to outright state this fact. The FDA also pointed to the fact that the commercials suggested Yaz is approved to treat acne of all severities when it is only approved for the treatment of moderate acne. In addition, the ads included close-up images of women with flawless, acne-free skin providing the “overwhelming impression” that taking Yaz as treatment for acne can completely clear the condition. Clinical studies cited in the package insert for Yaz found that only 15% and 21% of women had ‘clear’ or ‘almost clear’ skin ratings by the sixth cycle of treatment.

 

The FDA also stated that the ads failed to fully disclose the serious risks (such as blood clots) associated with using Yaz and that the background music and scene changes “distract from and make it difficult for viewers to process and comprehend the important risks being conveyed.” This was of particular concern to the FDA in light of the fact that Yaz carries serious, life-threatening risks.

As a result of this reprimand from the FDA, Bayer was forced to remove the ads from circulation, submit a remediation plan to the FDA, and launch a corrective advertising campaign. The new campaign ran from January through July of 2009 at a cost of $20 million.

Internet Advertisements

Bayer was again cited for its advertising of Yaz in March of 2009, when the FDA accused the company of failing to communicate the risks associated with Yaz in sponsored links on internet search engines such as Google. Federal law requires promotional materials to disclose risk and other information about the drug. The 2009 letter specifically addressed the following sponsored ad:

YAZ® Birth Control Pill www.Yaz-US.com YAZ® Prevents Pregnancy, May Help             Moderate Acne and PMDD.

 The FDA was particularly concerned over the failure of this ad to communicate risk information in light of the fact that Yaz carries significant, potentially life-threatening risks. Furthermore, the FDA asserted that the brief statement regarding the use of Yaz (“Prevents Pregnancy, May Help Moderate Acne and PMDD”) is incomplete and therefore misleading to consumers. In addition, the ad failed to present the full established name of the drug (drospirenone & ethinyl/estradiol) in compliance with federal law.

Similar to its actions in response to the 2008 FDA letter, Bayer was required to immediately cease the dissemination of the sponsored links and submit a plan for their discontinuation. The FDA also urged Bayer to review promotional materials for all other prescription drug products it promotes in the United States and follow the same course of action if it discovered similar violations for those products.

 Yasmin Advertisements

The marketing of Yasmin (the precursor to Yaz) has been similar to that of Yaz, and has accordingly come under scrutiny by the FDA. Berlex Laboratories manufactured Yasmin until the company was acquired by Bayer in 2006. In a 2003 letter from the FDA, Berlex received warning for misleading advertising of Yasmin in a 60-second television commercial titled “Goodbye Kiss.” The letter accused the ad of falsely implying that Yasmin was superior to other kinds of birth control pills and substantially minimizing risks. In the letter, the FDA stated that the ad raised “significant public health and safety concerns.”

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