Our Yasmin/Yaz/Ocella lawyers are investigating potential Yasmin/Yaz/Ocella lawsuits throughout the country. These cases have begun to settle in massive numbers. For the few cases that do go to trial, one leitmotif plaintiffs' lawyers can be expected to present at trials on the injury claims is issue - albeit tangential but important - of Bayer's overpromotion of Yaz/Yasmin.What Is Overpromotion?
Overpromotion is the term used by the FDA and lawyers for drug company advertisements that go beyond the scope of what a drug is actually approved for. In this case, YAZ was approved by the FDA in 2006 as an oral contraceptive (birth control), for treatment of premenstrual dysphoric disorder (PMDD) in women who use oral contraceptives, and later for treatment of women with moderate acne who use oral contraceptives. It is not approved for any other uses, so it is unlawful for Bayer to promote the drug to doctors or the public for other uses.What Did Bayer Do Wrong?
Bayer’s YAZ advertisements went over the top about the benefits and uses of their birth control pill. Specifically, they told doctors and patients that the drug was useful in treating symptoms associated with premenstrual syndrome (PMS) and treatment of acne (not just moderate acne). The FDA reacted strongly against these advertisements, and required Bayer to put out a new round of advertisements to correct for their overzealousness. Many of those ads from the new $20 million campaign are airing on television now.Which Advertisements Were Allegedly Unlawful?
Two specific television advertisements by Bayer for YAZ were responsible for overpromoting the drug. The first, titled “Not Gonna Take It,” stated “YAZ is the only birth control proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life. It can also help keep your skin clear.” In the commercial, women were kicking and punching symptom bubbles like “Irritability,” Moodiness,” “Bloating” and “Feeling Anxious.” The second, titled “Balloons,” had a similar statement as “Not Gonna Take It,” but featured other bubbles including “Fatigue,” “Muscle Aches,” “Headaches,” “Increased Appetite” and “Acne.”What Did The FDA Do About Bayer’s Allegedly Unlawful YAZ Advertisements?
None of the symptoms referred to in the YAZ ads are approved by the FDA for treatment by YAZ apart from the indicated uses. The FDA’s concern is that viewers of the advertisement may associate YAZ with treatment for those symptoms separate and apart from the specific uses for YAZ—that is, birth control, PMDD and moderate acne. In particular, this advertising indicates that Bayer was attempting to expand the use of YAZ for symptoms commonly associated with pre-menstrual syndrome, which is not an approved indication by the FDA.
The FDA took the rare step of requiring Bayer to air corrective commercials. Pursuant to a settlement agreement with the FDA and the attorneys general of 27 states, Bayer now must spend at least $20 million on the new ad campaign, and for the next six years will be required to submit all proposed YAZ ads to the FDA for screening before release.Where Can I Go For More Information?
For more information, visit our Yaz information page.Do I Have A YAZ Claim?
If you or a loved one has used YAZ birth control pills and suffered from deep vein thrombosis (blood clots), pulmonary embolism, gallbladder disease, heart attack and/or stroke, please call one of our YAZ attorneys at 800-553-8082 or click here for a free no obligation consultation.