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What Actions Has the FDA Taken in Regard to Yaz and Yasmin?
The FDA issued pharmaceutical company Bayer a warning in relation to the way it advertised Yaz. It misled consumers about the safety of Yaz and many women took it on the false belief that they were taking a ‘fourth generation’, clinically advanced birth control drug. The commercials effectively downplayed the risks involved in taking Yaz and Yazmin, so that women were not able to make a fully informed choice as to the dangers they were exposed to by taking this brand of birth control pill. As a result, many women suffered heart attacks, strokes and blood clots. Some have survived, but others have not been so lucky.
The FDA’s first warning letter was sent to Bayer in October 2008, which raised the concerns about the pharmaceutical company’s aggressive marketing methods and the way in which it apparently sought to minimize health risks while overplaying the benefits associated with taking the drug. The FDA ordered Bayer to correct its misleading advertising by clearly stating the risks posed to women who took Yaz or Yasmin. Bayer agreed to spend $20 million on this corrective advertising. Unfortunately this new campaign only began running in January 2009. By this time, Yaz was already one of the most popular birth control pills available in the United States: by 2007 annual sales of the drug had already topped $600 million.
However, this is not the only warning the FDA has sent to Bayer. It has also issued at least two further warnings about its aggressive marketing techniques, accusing them of false and misleading statements in light of the very serious effects that are being reported in association with use of Yaz and Yasmin. The FDA also sent a further warning in August 2009 about the manufacturing processes in one of its German production plants in which Bayer is alleged to have failed to conform to good manufacturing processes. This plant is particularly significant in that it manufactures key ingredients that are used to make both drugs. Bayer has also been accused by the FDA of hiding information relating to a number of batches of the drugs. It is alleged that concealment of this information allowed drugs being shipped to the United States when they should not have been released for distribution.
FDA inspectors who reviewed the German facility in March 2009 found ‘significant deviations’ from standard manufacturing practices relating to key components of the drugs’ make up. Bayer apparently took test results that were off-spec and diluted them with ‘good’ test results to make it appear that the quality of the active ingredients in the drug was better than it was. Beyer had previously responded to the inspection and the FDA’s concerns back in April, stating that the company believed that it had acted properly in averaging bad batches with good before reporting the overall results to the FDA. The FDA is now demanding to know how Bayer plans to ensure that its practices meet the FDA’s standards in accordance with federal regulations.
If you or a loved one has been injured as a result of taking Yaz or Yasmin, you may be able to make a defective drug liability claim against Bayer. Find out more by consulting an experienced attorney today.
