December 7, 2011 — In the ongoing lawsuit against Bayer AG regarding its birth control pills Yaz and Yasmin, a document has been unsealed in federal court in Illinois that shows Bayer had safety information about the drugs that it did not provide to U.S. regulators.
The document was written by Bayer’s own research team. It was an analysis that “demonstrated an increase in the U.S. reporting rate” for blood clots, which are one of the most serious side effects of using Yaz and Yasmin. The researchers also found that spontaneous reporting rates of blood clots were different for Yasmin. When Bayer provided U.S. regulators with safety information about the drugs, they excluded this document.
Bayer is facing intense pressure from the public and the Food and Drug Administration (FDA), after several studies found that a woman who takes an oral contraceptive that contains drospirenone (Yaz, Yasmin, Ocella, Zarah, Beyaz, Gianvi, Loryna, Safyral, and Syeda) may be up to 74% more likely to develop a blood clot, compared to women who use older, low-estrogen types of oral contraceptives.
When this increased risk is translated into real numbers, the increased risk seems small — roughly 10 out of 10,000 women taking a new type of oral contraceptive (containing drospirenone) will develop a blood clot, as compared to 6 out of 10,000 with the older pills. But because millions of women take these medications, tens of thousands of women may have experienced a blood clot. Blood clots may form in the body and break loose (called an “embolism”), travel through the bloodstream, and cause heart attack, stroke, pulmonary embolism, or death. At least 50 women have died as a direct result of taking these contraceptives.
Bayer faces roughly 10,000 lawsuits regarding Yaz and Yasmin. Many women bringing the suits argue that they were misled by Bayer’s aggressive marketing campaign, which promoted the new contraceptives as safer alternatives to other contraceptives, and also advertised benefits that were not indicated by the FDA.
The $270 million advertising campaign — an unprecedented size for an ad campaign for a birth control pill — featured women popping balloons labeled “moodiness” and “acne” while singing “We’re not going to take it.” The FDA sent Bayer numerous warning letters, in 2003, 2008, and 2009 regarding the ads, because they failed to mention serious side effects, and promoted off-label uses.
Yaz, Yasmin, and other drospirenone-containing contraceptives are not approved to treat PMS or severe acne. They can treat mild acne and the symptoms of Premenstrual Dysphoric Disorder (PMDD).
The new types of contraceptives are equally effective at preventing pregnancy as older, low-estrogen contraceptives, but they have a slightly higher risk of developing blood clots. It seems likely that, given this information, most women would choose the safer contraceptive. But because Bayer’s advertising campaign provided a selective view of the data, and obscured potential risks, these women contend that they were misled into choosing a riskier medication — which subsequently led to severe injury or death.
Why did Bayer market the drugs so aggressively? Women in the U.S. spend nearly $3.4 billion on oral contraceptives every year. Bayer’s marketing campaign successfully made Yaz and Yasmin the most popular birth control pill in 2008 and 2009, generating $1.58 billion in sales.
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