Bayer Healthcare has agreed to pay up to $24 million to settle Yaz lawsuits and Yasmin lawsuits brought by women who suffered gallbladder injuries that were allegedly caused by the popular birth control pills.
Thousands of women throughout the United States have filed a product liability lawsuit against Bayer, alleging that the drug maker failed to adequately warn about potential side effects of Yaz, Yasmin and other birth control pills that use the progestin drospirenone, including an increased risk of blood clots and gallbladder problems.
While Bayer has already paid more than $1 billion to settle Yaz and Yasmin lawsuits involving women who suffered a pulmonary embolism or deep vein thrombosis (DVT), the drug maker has previously refused to make any offers to resolve cases involving gallbladder problems from Yaz, which many women claim resulted in the need for gallbladder removal.
Bayer has maintained that women do not face an increased risk of gallbladder disease from Yaz and Yasmin compared to other oral birth control pills, and plaintiffs have faced substantial negative scientific findings, which many believe will make it difficult for individual lawsuits to succeed at trial.
The settlement agreement will result in payments of $2,000 to women who can establish that they suffered a gallbladder injury, and $3,000 for women who had their gallbladder removed. However, the total of all settlements the drug maker is willing to pay is capped at $24 million, resulting in a possible reduction in the individual awards on a pro-rata basis if the total of all awards would exceed the cap.
Details of the agreement were announced in a case management order (PDF) issued on March 19, by U.S. District Judge David R. Herndon, who is presiding over the federal Yaz litigation that has been centralized in the Southern District of Illinois.
The settlement was reached following negotiations between Bayer and a committee of lawyers representing women who filed lawsuits, which were overseen by Special Master Stephen Saltzburg. In addition to cases filed in the federal court system, the settlement also applies to cases filed in California, New Jersey, Pennsylvania and other state courts involving plaintiffs who allege they suffered gallbladder disease or gallbladder injuries from the use of a drospirenone-based birth control pill manufactured by Bayer or BarrTeva.
Under terms of the agreement, to participate in the settlement a lawsuit must be filed and served before the filing deadline of March 25, 2013 at 11:50 central time. Plaintiffs with cases pending that only involve allegations of gallbladder injuries then have until April 29th to “opt-out” of the settlement if they do not want to participate, subject to a one-time 30-day extension that may be requested.
For women who have filed lawsuits involving both gallbladder injuries as well as blood clot injuries, such as a stroke, pulmonary embolism or deep vein thrombosis, they must “opt-in” to participate in the settlement, with a deadline of April 29, also subject to a one-time 30 day extension that may be requested. However, the average Yaz settlements for pulmonary embolism and deep vein thrombosis injuries have been averaging over $200,000 per claim.
According to an annual report released by Bayer earlier this month, the drug maker had paid more than $1 billion to resolve 4,800 claims involving the blood clot injuries. Those claims have been strongly supported by a number of studies and reports that suggest users of Yaz, Yasmin or other drospirenone birth control pills face an increased risk of blood clots when compared to other oral contraceptives.
In the federal court system, the Yaz and Yasmin litigation has been consolidated as part of an MDL before Judge Herndon, and it has grown to become the largest consolidated litigation in the United States, with the total number of active cases surpassing the asbestos litigation last year.