Bayer Healthcare has settled about 70 cases involving the popular oral contraceptives Yaz and Yasmin. This is only a fraction of the 11,300 suits pending against the company, with claims alleging instances of injury or death because of Yaz, Yasmin or its generics. Many health concerns have been raised over these drospirenone-containing pills, mostly due to the increased risk of blood clots. The lawsuits claim that the manufacturer knew about these risks and purposely hid them from the public. Considering Yaz’s unethical marketing campaign in recent years, Bayer has already experienced a number of issues with the pills.
Yaz, and its predecessor Yasmin are combination oral contraceptives that incorporate drospirenone and ethinyl estradiol. The drugs are very similar, except that Yaz uses a 24 day active cycle while Yasmin utilizes the traditional 21-day cycle. Originally, these newer forms of birth control seemed beneficial, supposedly due to improved hormonal regulation. Additionally, Yaz seemed especially appealing to women because it was approved to treat premenstrual dysphoric disorder (PMDD) and moderate cases of acne.
Health professionals suspect that drospirenone is the primary agent responsible for increasing the risk of thromboembolism in users; one study funded by the FDA showed that women taking this type of birth control were 75% more likely to develop a blood clot.
In October 2008, the U.S. Food and Drug Administration (FDA) reprimanded Bayer for its misleading ads with regards to Yaz. The agency stated that the Yaz commercials were misleading; ads made it appear as though the drug was effective at treating PMS, a condition not approved by the FDA. It also overstated Yaz’s benefits on acne, implying that is proven to treat all kinds of acne, which is contrary to what is approved. Bayer was forced to issue corrective ads in February 2009.
Last December, Bayer experience even bigger blows to its reputation. Former FDA commissioner David Kessler publicly reprimanded the company for violating FDA regulations. According to his report, Bayer hid the risks of thromboembolic events from the agency. Shortly afterwards, an advisory panel voted in favor of changing labels on Yaz, Yasmin, Beyaz, Sefyral and its generics to properly include the risk of blood clots, which could be fatal.
The mounting litigation against Bayer Pharmaceuticals began in 2009. The multidistrict litigation (MDL), consolidated in October 2009, has been set to take place before US District Court Judge David Herndon in the Southern District of Illinois. The first bellweather case was supposed to take place this January, but the judge opted for a mediator in attempt to settle outside the courtroom.
Judge Herndon’s move seems to have had at least a partial effect in light of the 70 cases that Bayer has agreed to settle. The company states in its 2011 annual report that, “As of Feb. 13, 2012, Bayer has reached agreements, without admission of liability, to settle the claims of approximately 70 plantiffs in the U.S. at terms and conditions which Bayer views to be reasonable.” cites Lawyers USA Online. The terms of settlement, however, are unknown to the public. These settlements are only the beginning of a long legal process for the manufacturer. Although some progress has been made, the litigation is far from over.