Yaz and Yasmin Legal Woes Mount for BayerSep 27, 2009 | Parker Waichman LLP
Bayer Healthcare is facing a raft of legal troubles over its popular birth control pills, Yaz and Yasmin. According to The New York Times, at least 74 lawsuits have been filed by women who claim either Yaz or Yasmin caused health problems, including heart attacks, strokes and blood clots.
Yasmin and Yaz are both low estrogen oral contraceptives. Yasmin was approved in the U.S. in 2001, while Yaz, which contains even less estrogen, was approved in 2006. Together, the pills generated about $1.8 billion last year for Bayer HealthCare, which according to The New York Times, has positioned them as the "go-to drug brands for women under 35." Yaz, which is the top-selling birth control pill in the U.S., has been marketed by Bayer as "a quality-of-life treatment to combat acne and severe premenstrual depression," the Times said.
The estrogen in all birth control pills is known to increase the risk of heart attacks, blood clots and strokes. According to the Times, the advent of lower-dose estrogen pills, such as Yaz and Yasmin, has sparked a debate over whether the type of progestin in an oral contraceptive can play a role in such problems. Critics of Yaz and Yasmin believe it can.
Both Yaz and Yasmin contain a type of progestin called drospirenone. As we've reported previously, drospirenone is known to carry some health risks not seen with other forms of the hormone. Most notably, it can increase the levels of potassium in the blood, which can lead to a disorder called hyperkalemia in high risk patients. This condition may result in potentially serious heart and health problems, including fatal cardiac arrhythmias. High potassium levels are especially dangerous for people who are obese, or who have diabetes or high blood pressure.
Bayer insists that both Yaz and Yasmin are safe. According to the New York Times, the drug maker cites a large European study that it paid for that reported that there was no difference in the risk of cardiovascular problems or death in women taking drospirenone contraceptives compared to women who took pills that contained a progestin called levonorgestrel.
But as we reported previously, not all studies on the subject have been as reassuring. For example, a Dutch study recently published in the British Medical Journal found a 6.3-fold increase in venous thrombosis - a life-threatening type of blood clot - in women taking drospirenone contraceptives compared with women not taking any type of pill. Contraceptive pills containing levonorgestrel, however, increased the risk of clots by only 3.6-fold. According to The New York Times, Dr. Frits R. Rosendaal, one of the authors of the Dutch study, said the risk was "worth acting on" and advocates that women switch to a pill that contains levonorgestrel.
Almost in every Yasmin and Yaz lawsuit it is alleged Bayer overstated their benefits and failed to adequately warn of their risks. In October 2008, the FDA issued a warning letter that made similar allegations about two television ads Bayer was running to promote Yaz. As we reported previously, Bayer ended up pulling the misleading ads. It also reached an agreement with the FDA and 27 state attorneys general to run new TV spots correcting the misinformation from the pulled commercials. They began running in early 2009.
In August, Bayer received another FDA warning letter involving a German plant that makes, among other things, drospirenone. As we reported earlier this month, the letter said Bayer used a testing method on ingredients made at the plant that did not meet U.S. standards.
Now, Reuters is reporting that Swiss health regulators are investigating the death of a young woman who was taking Yaz. The death occurred in mid-September, after the victim suffered a pulmonary embolism. She had been taking the drug for 10 months. According to Reuters, Swissmedic began investigating all birth control pills after a 16-year-old girl was disabled by a lung embolism in May after taking Yaz.