In 2008, Bayer Pharmaceuticals released a pair of television commercials for the birth control pill Yaz. The TV ads—entitled “Not Gonna Take It” and “Balloons”—stated that in addition to the contraceptive benefits of Yaz, women who took the birth control pill may also be able to treat symptoms associated with pre-menstrual syndrome (PMS) and acne.
Later that year, Bayer received a warning letter about the Yaz commercials from the Food and Drug Administration. The FDA’s Yaz warning stated that the commercials violated federal law because they marketed the drug for conditions it was not approved to treat, overstated its effectiveness and understated the risk of side effects associated with Yaz.
Although Yaz was approved by the FDA to treat pre-menstrual dysphoric disorder (PMDD)—a serious menstrual condition that can severely impact quality of life—the drug was not approved to treat women with PMS. According to the FDA, the Yaz advertisements stated that the drug could cure a number of PMS symptoms, implying that the birth control pill was approved to treat the condition.
The agency also faulted Bayer for implying that Yaz could completely rid patients who take the birth control pill of acne symptoms. Although the FDA approved Yaz for the treatment of mild acne, the agency stated that Bayer’s advertisements implied that the drug was more effective at treating the condition than had been scientifically proven.
The FDA also stated that the Yaz TV commercials did not properly warn about the risk of side effects associated with the drug. According to recent studies, women who use Yaz are twice as likely as users of another type of birth control to develop blood clots. In its warning letter to Bayer, the FDA stated that the company’s commercials for Yaz did not properly warn about the potentially life-threatening side effects that women who use Yaz may experience.
As a result of these violations, the FDA—in conjunction with the attorneys general from 27 states—forced Bayer to air a $20 million ad campaign to correct its misstatements about the effectiveness and side effects of Yaz. The new ad campaign—comprising both magazine ads and new television commercials—was scheduled to run for six years starting in 2009.
If you or a loved one used Yaz or Yasmin and suffered blood clots or other side effects, you may qualify to file a lawsuit. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.