Eager to enter the oral contraceptive market with their proprietary progestin, Drospirenone (DSRP, the active hormonal ingredient in Yaz and Yasmin), Bayer Healthcare Pharmaceuticals recognized an opportunity in a woman's need for mood control related to menstruation as a ticket to massive profits. But Bayer faced one problem; the science behind their drugs Yasmin and Yaz would only support FDA-approved indications for the prevention of pregnancy and the treatment of a severe and debilitating disorder known as Prementrual Dysmorphic Disorder (PMDD). Unlike PMS, a diagnosis of PMDD involves months of observation and tracking of a woman's cycle. Only 3%-8% of woman who menstruate suffer from PMDD. However, when polled, nearly 75% of all women did not know the difference between PMDD and PMS. It was this confusion that Bayer preyed upon when marketing Yasmin and Yaz to the public. Bayer conducted studies that demonstrated no difference between Yasmin/Yaz and a placebo when it came to treating PMS. Due to these results, Bayer was never able to obtain FDA approval for the treatment of PMS with Yasmin or Yaz. Furthermore, Yasmin and Yaz's third indication, for the treatment of moderate acne, was based on science that barely demonstrated any improvement above and beyond a sugar pill.
In October 2008, after releasing multiple nationwide television commercials in which perfectly complexioned actresses said "goodbye" to their premenstrual symptoms, the FDA served Bayer with a Warning Letter demanding that the commercials be pulled from television. Bayer was also instructed to destroy marketing materials used in the field and inside doctor's waiting rooms.
By the time Bayer was able to comply with an FDA mandate to spend $20 million in running corrective advertisements, Bayer had managed to convince enough women of the unsubstantiated benefits of Yasmin and Yaz that the drug was making nearly $2 billion in revenue annually.
But Bayer's deceptive and reprehensible conduct doesn't end there. Besides fraudulently inducing patients to seek out their products for unapproved uses, Bayer systematically contaminated the body of scientific research surrounding the 3rd and 4th generation of combined oral contraceptives.
A study was conducted by Dr. Ojvind Lidegaard and utilized the Danish National Registry to develop a retroactive cohort analysis of the safety of combined oral contraceptives. Dr. Lidegaard's study demonstrated that there was a significantly increased risk for VTE and PE associated with DRSP compared to other similar products on the market. These findings were completely contrary to Bayer's publci assertions as to the safety of Yasmin/Yaz.
Bayer set plan in motion to discredit the findings.
Because Bayer's damage control machine was hard at work within minutes of Lidegaard's first publication, the true risk of DRSP would not be fully realized or accepted until more than two years later. Within that time, Bayer made nearly $4 billion from Yasmin and Yaz.
On October 26, 2011, the British Medical Journal published yet another study by Dr. Ojvind Lidegaard, that again demonstrated a significantly higher risk of Venous Thromboembolism (VTE) for users of the 3rd and 4th generation Combined Oral Contraceptives involving DRSP.
Dr. Lidegaard and his colleagues found that, compared to women not using hormonal contraceptives like Yaz and Yasmin encountered a six-fold increase in risk for VTE and Pulmonary Embolism (PE), a somewhat higher rate of risk than that found in the Lidegaard I study.
An FDA study found that young women who use Yaz and Yasmin have been putting women at a significantly higher risk without providing any additional benefit over other, older contraceptives. It also proves that Bayer's past and present labeling vastly understates the risks associated with Yasmin and Yaz.
The insufficiency of the labeling for Yasmin and Yaz has been confirmed by the recent voting results of the Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. The Advisory Committee panel, voting 21 to 5, expressed a resounding "no" when asked if the current labeling for DSRP-containing oral contraceptives "adequately reflect[s] the risk benefit profile" for those drugs. Secondly, when asked if the benefits of DRSP-containing oral contraceptives outweigh their risks, the panel voted 15 yes, to 11, nearly sounding the death knell for Bayer's "blockbuster" drug that has been the company's bread and butter.
Unfortunately, despite the litany of new science and these recent Advisory Committee findings, Bayer Pharmaceuticals still refuses to acknowledge the dangers that their drugs have created.
To date, the only studies that indicate that DSRP containing oral contraceptives do not increase risk of thrombotic events are studies that have been paid for by Bayer Pharmaceuticals. Every other independent study that has considered the issue, seven studies in all, indicates that DSRP significantly increases a woman's risk of suffering an injury related to blood clotting.
Undoubtedly, healthcare providers and patients alike cannot make informed choices unless the information drug companies provide is accurate and truly reflects the risks and benefits of a possible treatment option. Unfortunately for many women, true and accurate information about Yaz and Yasmin may come too late. And even now, nearly two years after the alarm bells began to sound, after hundreds of thousands of new prescriptions, and millions of pills popped, Yaz and Yasmin remain on the market.
As of August 1, 2012, Bayer has announced that it has reached settlements totalling over $402 million for U.S. lawsuits claiming that its Yaz, Yasmin, and Ocella (the generic form) birth control pills caused blood clots in women.
Your Legal Options
Our attorneys are currently evaluating cases related to Yasmin and Yaz. If you suffered an adverse side effect while taking Yaz or Yasmin, such as blood clots, deep vein thrombosis, strokes, or a heart attack, please contact us through this simple form or our toll-free number, 800-598-0314.
