The Judicial Panel on Multidistrict Litigation (JPML) began consolidating claims against Bayer and other pharmaceutical companies related to the oral contraceptive Yaz in 2009. Since then, the multidistrict proceeding has grown to include more than 11,000 cases. In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, No. 3:09-md-02100 (S.D. Ill.). According to the JPML, 9,550 cases are still pending as of March 13, 2014, although Bayer has reportedly reached settlement agreements in many of those cases. Controversy over the drug began with claims about inaccurate information and insufficient warnings in television commercials for the drug, followed by products liability lawsuits.
Yaz and Yasmin were brand names for a synthetic hormone-based birth control medication containing a diuretic known as drospirenone,. It was approved by the U.S. Food and Drug Administration (FDA) for use as an oral contraceptive. Drospirenone has been associated with an increased risk of thromboembolism, a dangerous type of blood clot that blocks all blood flow in a vein or artery and can lead to heart attack or stroke.
Television ads for the drug in 2008 claimed that Yaz could treat mild acne and premenstrual dysphoric disorder (PMDD). The FDA and attorneys general in twenty-seven states required Bayer to run new ads beginning in early 2009, based on allegations that the company had overstated Yaz’s ability to treat acne and PMDD, and had understated the risks of the drug. In April 2012, the FDA ordered Bayer to change the label on Yaz and related medications to include warnings about the higher risk of blood clots associated with drugs containing drospirenone.
An early lawsuit by a woman who took Yaz asserted causes of action for products liability, negligence, fraud, and breach of warranty. Seagraves v. Bayer, et al, No. 22669/09, complaint (N.Y. Sup. Ct. Westchester Co., Oct. 2, 2009), removed to No. 7:10-cv-04280 (S.D.N.Y., May 27, 2010). The plaintiff took Yaz between August and October 2007, and alleges that she will require medical monitoring for the rest of her life due to the risk of thromboembolism and related complications. She claims damages for pain and mental anguish along with the cost of medical monitoring.
The JPML consolidated thirty-two pending lawsuits against Bayer and other companies in the Southern District of Illinois on October 1, 2009. The purpose of consolidating cases is to maximize the efficiency of resolving pre-trial issues when numerous cases address similar issues. In this case, all of the lawsuits had common questions involving oral contraceptives containing drospirenone. According to the District Court for the Southern District of Illinois, the case grew to include 11,703 separate lawsuits with 12,898 total plaintiffs. Bayer’s 2013 annual report stated that the company has has paid approximately $1.69 billion to settle about 8,250 U.S. lawsuits.
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