New Yaz, Yasmin Lawsuits Filed
Yaz, one of the most popular U.S. contraceptives and its predecessor Yasmin, raked in about $1.8 billion for maker Bayer in 2008. The U.S. Food & Drug Administration (FDA) has warned and fined Bayer for deceiving television ads that overstated both drugs efficiency and minimized their grave risks. Now, over 50 more women have alleged in lawsuits that they experienced strokes, heart attacks, and various other significant maladies from taking the drugs, reports the IndyStar. Yasmin has been marketed since 2001 and Yaz since 2006.
The suits, filed in Indianapolis, add to the plethora of others nationwide by dozens of women over recent months, said IndyStar; all claim similar problems. Plaintiffs allege Yaz was not subjected to adequate testing, and that Bayer failed to provide appropriate warnings about potential side effects. According to Bayer, Yaz and Yasmin are safe when used as directed and also, said Bayer, all oral contraceptives contain warnings for potential side effects, said the IndyStar.
Yaz has been linked to detrimental side effects including blood clots, heart attacks, strokes, gallstones, and gallbladder disease. The Indiana lawsuits allege complaints of blood clots and pulmonary embolisms in plaintiffs’ legs and lungs; some necessitated gallbladder surgery. Other women suffered strokes that permanently disabled them, stated the IndyStar, citing Yaz lawsuit attorneys.
Yaz, Yasmin and generic Ocella differ from many other contraceptives because of their composition. They are made with a form of progestin called drospirenone that can elevate the body’s potassium levels. As a result, some people can experience hyperkalemia, a condition that could cause severe heart and health afflictions. Adverse Events reported to the Food and Drug Administration (FDA) that associated Yaz and Yasmin problems 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.
The British Medical Journal recently published a Dutch study comparing drospirenone and levonorgestrel contraceptive pills. Their findings illustrate the questionable safety of Yaz and Yasmin. Women taking drospirenone increased their chance of a life-threatening blood clot (venus thrombosis) by 6.3-fold compared with those not on any pill. Levonorgestrel increased clot risk by only 3.6-fold. The significant difference prompted one study author to recommend women switch to a levonorgestrel containing pill.
In response to the filings, Bayer argued, “… the complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours,” said spokeswoman Rose Talarie, quoted the IndyStar. “Bayer’s oral contraceptives are safe and effective when used according to product labeling.”
Recently, all Yaz and Yasmin lawsuits currently 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). In December, Judge Herndon discussed scheduling “bellwether” trials for the lawsuits that would serve as guidance for other cases. Some legal experts speculate that as many as 25,000 Yaz and similar medication lawsuits could be filed in the multidistrict litigation, which could take more than two years to resolve.
Although Yaz and Yasmin fattened Bayer’s bank account by $1.8 billion last year, it’s unclear how they will fare after court proceedings. They have been in trouble before for unrealistic product claims and deceptive glossy advertising.
One would think that all the negative publicity and allegations would deter women from considering these contraceptives.

Posted on Monday, February 8th, 2010 at 8:20 pm under 