Four significant lawsuits have been filed in federal courts against Bayer HealthCare Pharmaceuticals involving the safety of Yaz and Yasmin, two of its popular birth control pills. The lawsuits were filed last month in federal courts – three in Ohio, one in Wisconsin – and there will be more to come. Bayer had reached an agreement with the Food and Drug Administration in 2008 to run a $20 million corrective ad campaign for overstating the benefits of Yaz and downplaying its risks. The FDA had issued Bayer a warning letter about the ads, noting that Yaz actually has additional risks compared to other birth control pills because it contains the progestin drospirenone, which can increase potassium levels.

There are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer. Yaz received FDA approval in 2006 and Yasmin in 2001. Doctors are largely unaware of these adverse events unless they figure it out for themselves. The drug companies have known about the adverse effects for some time, but have failed to warn the doctors or their patients.

The lawsuits allege that Bayer failed to warn women and their doctors of the pills’ increased risk of injury – most notably blood clots – while over-promoting the benefits of the drugs. The FDA letter will be used as evidence in this litigation. Janet G. Abaray, a lawyer in the Cincinnati office of Burg Simpson Eldredge Hersh & Jardine, is representing the Plaintiffs in the four cases referred to above.

Source: Law.com

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