Chicago, ILWhile Yasmin birth control and its close cousin Yaz have been around for barely a decade, lawsuits tied to the oral contraceptive duo have now surpassed asbestos as the largest pending litigation in the country, according to reports. Considering that the dangers of asbestos have been known for a hundred years, the story of Yasmin's rapid rise in popularity and an equally rapid reversal of fortune in one tenth the time, is a substantial occurrence.
Yasmin and Yaz contain drospirenone, a synthetic hormone which, according to manufacturer Bayer Pharmaceuticals, carries a number of benefits important to women, not the least of which is reduced bloating and water retention, and even improved skin.
However, it is widely held that Yasmin side effects include an increased potential for blood clot or deep vein thrombosis (DVT). Various Yaz lawsuits allege serious health issues associated with both Yaz and Yasmin, and there have been deaths—some as young as 17, according to reports.
There is much pressure on the US Food and Drug Administration (FDA) to pull the still-popular contraceptives from the market. The FDA's own study suggested a 1.5 fold increase in the potential for Yasmin DVT and blood clot associated with drospirenone-based Yaz, v. older birth control pills that do not contain drospirenone.
And yet the FDA appears to be adopting a wait-and-see approach in the face of conflicting studies. Some have suggested a dramatic rise in the risk of Yasmin blood clots (together with Yaz), whereas others demonstrate little potential for harm beyond the minimal blood clot risk normally associated with all forms of oral contraception.
To complicate matters further, four members of an FDA review panel voting to keep Yasmin and Yaz on the market allegedly maintained ties to Bayer. Had that potential for conflict not been a factor, it's possible that a tie vote would have ensued and a different outcome seen. The FDA is not obligated to follow the recommendations of expert panels but historically, it usually does.
Various advocates are lobbying the FDA to re-open the debate over Yaz side effects and Yasmin, without the participation of the four panelists with alleged ties to Bayer.
In the meantime Yaz lawsuits, and corresponding litigation over Yasmin, continues. A woman recently filed a Yaz lawsuit in Illinois, alleging she developed blood clots, pulmonary emboli, pulmonary infarction and deep vein thrombosis, after taking the contraceptive for several months in 2007.
Beyond the issuance of safety bulletins, the FDA appears to have no plans to act upon issues relating to the Yasmin pill, which include Yasmin gallbladder problems.
As for Bayer, various figures have been bandied about pertaining to amounts already paid out by the manufacturer to settle some lawsuits, while additional lawsuits remain pending and new Yasmin and DVT lawsuits continue to be filed. It has been reported that as much as $1.5 billion may be needed to settle all current and pending litigation.
In the meantime it has been reported that Bayer has invested in the non-prescription drug industry with the purchase of Schiff Nutrition International, a health supplement company. Purchase price was reported to be $1.2 billion. The purchase, according to Dolan Media Newswires (11/7/12), was seen as an attempt to lower Bayer's exposure to litigation and Yasmin lawsuits. Given that Yasmin and Yaz have reportedly surpassed asbestos, the exposure is arguably substantial.
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