The first bellwether trial in the federal Yaz and Yasmin product liability litigation has been postponed. According to a report from FiercePharma, U.S. District Court Judge David Herndon, who is overseeing the multidistrict litigation, has ordered the Yaz and Yasmin lawsuits to mediation.
The makers of Yaz, Yasmin and similar birth control pills made with drospirenone, a synthetic progestin, have been named in more than 10,000 lawsuits claiming the drugs caused young women to suffer dangerous blood clots and other serious side effects. The cases have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before Judge Herndon in the U.S. District Court for the Southern District of Illinois. According to a Bloomberg News report, plaintiffs’ lawyers have cited reports of at least 50 deaths tied to the pills from 2004 to 2008.
As we’ve reported previously, since 2009 a total of five large studies have found evidence that drospirenone birth control pills pose a higher risk of blood clots compared to those containing an older form of progestin. Only two large studies, both funded by the maker of Yaz and Yasmin, have failed to find a higher risk. Most recently, a study commissioned by the U.S. Food & Drug Administration involving more than 800,000 American women taking some birth control between 2001 and 2008 found that those taking pills with drospirenone were 75 percent more likely to experience clots compared to those taking other oral contraceptives.
Just last month, a panel of FDA medical advisors recommended that labels for Yaz, Yasmin and similar pills be updated with stronger warnings about their possible potential to cause serious, life threatening blood clots. The panel voted 21 to 5 in favor of changing the labels for Yaz, Yasmin and similar birth control pills, holding that current label warnings are inadequate. The FDA is not legally obligated to follow the recommendations of its outside advisory panels, but it usually does so.
The first test trial in the Yaz and Yasmin litigation was supposed to start next week. But in an order dated December 31, Judge Herndon appointed a special master, George Washington law professor Stephen Saltzburg, to mediate. The Judge directed Saltzburg to explore the possibility of “settlements in this litigation,” and ordered attorneys for both plaintiffs and defendants to meet with him “without delay” to negotiate in good faith. According to FiercePharma, Saltzburg previously handled mediation for more than 20,000 Seroquel product liability lawsuits.
Judge Herndon’s order puts the rest of the Yaz and Yasmin bellwether trials in limbo, FiercePharma said. Last year, he had promised to press for settlements in the lawsuits after the test trials were finished, but now it appears the Judge is pushing for a faster resolution.