Progress in Yaz, Yasmin MDL

The multidistrict litigation involving Yaz and Yasmin is moving ahead. At a recent status conference, the judge overseeing the litigation discussed the establishment of “bellwether” trials with attorneys for both plaintiffs and defendants.

Yaz and Yasmin and a generic birth control pill called Ocella are all made with a type of progestin called drospirenone, making them different from many other oral contraceptives. Drospirenone can elevate the body’s potassium levels, which can lead to a condition called hyperkalemia in certain patients. Hyperkalemia may result in potentially serious heart and health problems. Adverse Events reported to the Food & Drug Administration (FDA) involving Yaz and Yasmin include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.

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.

Yaz is the top-selling oral contraceptive in the U.S. Last year, Yaz and Yasmin generated about $1.8 billion for Bayer. The manufacturers of Yaz and Yasmin have been warned at least three times by the FDA over misleading television advertisements which overstated the efficiency the drugs and minimized their serious risks.

Around 300 women have filed lawsuits against Bayer over Yaz and Yasmin. Plaintiffs claim they suffered strokes, pulmonary emboli, deep vein thrombosis, blood clots, gallbladder disease, and other serious injuries after taking Yaz and Yasmin. They allege that Yaz and Yasmin were not subjected to adequate testing, and that Bayer failed to provide adequate warnings about their potential side effects.

On October 1, 2009, all Yaz and Yasmin lawsuits pending in federal court were consolidated for centralized and coordinated pre-trial proceedings in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation in the United States District Court for the Southern District of Illinois before Judge David R. Herndon (MDL No. 2100). The establishment of bellwether trials were discussed at a December 17 status conference, with Judge Herndon indicating that “the Court like this case to move along efficiently and effectively.”

An agreement has already been reached between plaintiffs’ and defendants’ attorneys on aprotective order concerning the handling of confidential information disclosed during the litigation. Bayer was expected to produce more than 1 million pages of documents this week as part of the discovery process.

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