Yaz Birth Control Lawsuit - Consumer Drug Report
FDA advisory committee ordered to conduct new Yaz and Yasmin meeting

On December 8, 2011, the FDA advisory panel met to discuss the benefits and risks of birth contraceptives Yaz® and Yasmin®. In a vote of 15 to 11, the panel determined that the contraceptives offered more benefits than risks despite rising concerns associated with new generation birth controls such as Yaz and Yasmin.

However, recent documents reveal that some of the advisory committee members previously worked for Bayer, the manufacturer of Yaz and Yasmin. Though the FDA knew about the three panel members prior work with Bayer, this evidence may not have been revealed had it not been discovered during the Yaz and Yasmin lawsuits. Some suggest that the panel members’ prior connection with Bayer created a conflict of interest, thus altering the true validity of the members’ votes.

On January 11, 2012 the Project on Government Oversight wrote a letter to FDA commissioner Margaret Hamburg requesting that a new meeting be arranged. The letter states “We are troubled by the industry ties of some of the FDA joint committee members who reviewed the safety of Yaz and Yasmin on December 8, 2011. Because of the industry ties of these members, the joint committee’s conclusion – which amounted to an endorsement of the safety of these oral contraceptives – should be disregarded.”

Bayer now faces over 10,000 Yaz and Yasmin lawsuits brought by women who claim they were injured by Yaz and Yasmin. Judge David R. Herndon, the federal judge presiding over these lawsuits has ordered the parties involved in the lawsuits to meet with an assigned mediator in an attempt to negotiate a settlement for the litigation. As a result, the first trial, which was originally scheduled to begin on January 9, 2012, has been pushed to a later date.

If the parties are unable to reach a settlement, the first bellwether trial will begin on April 30, 2011.


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