Ninety-eight percent of American women take birth control pills at some point in their lives. The hormonal contraceptives market is estimated to be worth about $4 billion, with $2.5 billion coming from sales in the United States. With over 60 different types of birth control pills to choose from, and so much money to be made, pharmaceutical companies do whatever they can to make their version of the birth control pill seem newer, better, and more appealing to American women. Unfortunately, in the drive to achieve popularity, some pharmaceutical companies lose sight of what is most important: women’s safety. Yaz is one pill that has been aggressively marketed to young women despite the fact that it may carry greater health risks than any other oral contraceptive on the market.

What Is Yaz?
Yaz is an oral contraceptive developed and distributed by Bayer HealthCare Pharmaceuticals, Inc. (Bayer). An earlier version of the same pill was known as Yasmin. Ocella is the generic version of Yaz and is also made by Bayer but marketed and distributed by Barr Laboratories, Inc. (Barr). Ocella works the same way as Yaz and carries the same risks.

Like many other birth control pills, Yaz is made up of estrogen (“ethinyl estradiol”) and a synthetic progestin. There are several different types of progestin commonly used in oral contraceptives, but Yaz uses drospirenone, a new progestin that is not used in any other birth control pill available (other than Ocella).

In 2008, Bayer launched a massive marketing campaign for Yaz, including television commercials that were viewed by millions of Americans. The commercials advertised Yaz as being a unique oral contraceptive that could treat acne, symptoms of premenstrual syndrome (PMS), and premenstrual dysphoric disorder (PMDD, a severe form of PMS).

Today, Yaz is the most popular birth control pill in the United States, bringing Bayer around $1 billion in annual revenues.

Why Is Yaz Dangerous?
The use of Yaz has been linked to blood clots (deep vein thrombosis and pulmonary embolism), stroke, gallbladder disease and gallbladder complications, heart attack, and death.

All oral contraceptives carry some risk of cardiovascular problems, especially in women over the age of 35 and women who smoke. But Yaz appears to carry a higher risk and may cause more health problems even in younger women than other birth control pills.

A British Medical Journal study released in August 2009 confirmed that Yaz carries a 6.3 times increased risk of deep vein thrombosis or pulmonary embolism. Compared to using some other types of oral contraceptives, Yaz carries about a four times greater risk of these health problems.

The study suggests that the new progestin used in Yaz, drospirenone, is responsible for the increased health risks associated with Yaz. A possible explanation is that drospirenone has a diuretic effect, while other birth control pills do not contain diuretics. Diuretics must be taken with caution because there is a possibility that the patient will lose too much water and sodium.

Misleading Advertisements
While the dangers of taking Yaz are significant, also of concern is the fact that these dangers were downplayed in advertising. Bayer’s marketing strategy for Yaz has been criticized widely. In October 2008, the U.S. Food and Drug Administration (FDA) sent Bayer a warning letter, criticizing their television ads and demanding a corrective advertising campaign. Ultimately, Bayer was forced to spend $20 million to fulfill its obligation to the FDA and correct the misleading image of Yaz it had painted for American women.

Early advertisements for Yaz downplayed the risks of the drug, targeted young women, and suggested that Yaz could be taken to treat acne, PMS, and PMDD.

The FDA blasted Bayer for marketing Yaz for unauthorized uses. According to the FDA, Yaz should only be used to treat acne in women who want to take an oral contraceptive. Yaz is not approved as a treatment for PMS, which affects up to 80 percent of women. Yaz has been approved to treat PMDD, a very severe type of PMS which only affects about ten percent of women. However, it is only recommended for those PMDD sufferers who wish to take an oral contraceptive.

By way of example, one of the ads in question featured energetic young women kicking and punching words off the screen. The words included “irritability,” “bloating,” and other symptoms commonly associated with PMS. Without a statement clarifying that Yaz was never evaluated as a treatment for PMS, the ads may have misled many young viewers into thinking that taking Yaz would get rid of their PMS.

The FDA also expressed extreme concern about the way the ads downplayed the dangers of Yaz. Although the commercials included a statement of the risks involved in taking Yaz, the statement was a mere voice-over read while complex visuals were displayed, making it difficult for viewers to comprehend the significance of the risks being conveyed. The FDA stated that this was very troubling considering that some of the risks are serious and life-threatening. The effect of the distracting and complex visuals undermined the importance of the communication, minimized the risks, and made it seem as though Yaz was safer than it actually was.

Growing Numbers of Lawsuits
Between the sudden popularity of Yaz and the higher health risk involved in taking Yaz, large numbers of women have recently experienced significant health problems that they attribute to taking either Yaz or Ocella. In response, hundreds of these women have recently filed dangerous drugs lawsuits against Bayer and Barr. In fact, so many cases have been filed that many actions have been consolidated into multidistrict litigation. This allows plaintiffs to share information so that the defendants only have to go through discovery once, rather than hundreds of times.

Yaz and Ocella remain on the market even as hundreds more lawsuits are believed to be forthcoming.

Dangerous drug cases are a type of products liability case. In products liability, it is not necessary to prove that the manufacturer was negligent. To establish liability on the part of the drug company, it is only necessary to show that a dangerous or defective drug was placed on the market and later caused injury. Pharmaceutical companies may be held liable for any of the following:

• Manufacturing a dangerous drug
• Manufacturing a defective drug
• Improperly marketing a drug
• Inadequate warnings
• Inadequate or incorrect instructions

We Can Help
Yaz and Ocella are associated with an increased risk of blood clots (deep vein thrombosis and pulmonary embolism), stroke, gallbladder disease and gallbladder complications, heart attack, and death. If you lost a loved one after they took Yaz or Ocella, or if you were prescribed Yaz or Ocella and you later experienced health problems, seek advice from an experienced pharmaceutical products liability attorney. A lawyer can answer your questions, explain your options, and help you make an informed decision about how you wish to proceed. In and around New York City, contact the law firm of Leandros A. Vrionedes, P.C. for professional advice and representation in cases involving dangerous and defective drugs.