The Cochran Firm Legal Blog

By Farrest Taylor, Esq. and Catherine Walding, Legal Editor
Consumers have a right to expect truth in the advertisements they see, read, and hear. While consumers understand that companies are trying to sell a product, they also tend to assume that companies don't misrepresent or omit important facts concerning their product, as we know the Federal Trade Commission monitors these advertisements. According to FTC regulations:

• Advertising must be truthful and non-deceptive;
• Advertisers must have evidence to back up their claims; and
• Advertisements cannot be unfair.

In a perfect world, companies would adhere to these rules in a sense of simple fairness. Unfortunately and too often, advertisements are misleading, containing omissions and outright misrepresentations.

Recently, Bayer Healthcare Pharmaceuticals, Inc. has come under fire for allegedly misleading advertisements for their birth control pills Yaz and Yazmin. Containing a form of progesterone called drospirenone, Yaz and Yazmin have the potential to raise the potassium level in a woman's body to such levels as to increase the likelihood of possible blood clots, stroke, heart attacks, and death.

Information about such dangerous side effects was not communicated to women using these products, while, at the same time, information about the efficacy of the products for other needs such as acne treatment was exaggerated and overstated. For example, Bayer failed to relate that their product is only indicated for moderate acne vulgaris, rather than all types of the skin disease.

The same ad implied that Yaz decreases the problems associated with Premenstrual Dysphoric Disorder (PMDD), despite Bayer having little or no evidence to back up such claims. Further, in the TV commercial, "Balloons," PMDD seems to have been deliberately confused with the more common Premenstrual Syndrome (PMS), leading women to believe that Yaz could help the similar symptoms of PMS, though the studies involved women with PMDD only. In a warning letter to Bayer, dated October 2, 2008, the Food and Drug Administration stated that two television ads "misleadingly suggest that Yaz is effective in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience."

More importantly is the omission of dangerous side effects related to Yaz. In the same letter cited above, the FDA warned Bayer that the statement of such side effects given during the television commercial was unduly minimized by "distracting visuals, numerous scene changes, and other competing" effects which served to minimize the effect of the statement. Even as Bayer agreed to pull these ads, they continued the same marketing via the internet. A second letter dated March 26, 2009 revealed the FDA's concern about the internet marketing employed by Bayer, stating to the pharmaceutical company that the sponsored links leading consumers to the Yaz website failed to include any information concerning the risks of taking Yaz. This failure leads consumers to believe that Yaz is safer than has been found.

The end result of this marketing is that women who are at risk for the serious side effects are not sufficiently warned while, at the same time, they are drawn to the supposed benefits of Yaz, even in cases where they may not need or want birth control. Bayer laid claim to the benefits of their product without the proper evidence required by the FDA, putting millions of women at risk with their omission of the possible serious side effects.

If you have been harmed while taking Yaz, please contact The Cochran Firm today.

Labels: main