The first Yaz trial won't open as scheduled. A federal judge delayed the bellwether patient lawsuit, set for trial next week, and appointed a special master to mediate instead. And this special master is well versed in pharma liability litigation: It's George Washington law professor Stephen Saltzburg, who handled mediation in 26,000 Seroquel lawsuits.
Judge David Herndon, who's overseeing litigation over Bayer's birth control pills, had promised in the fall to press for settlements after the bellwether trials wrapped up. But in an order filed Dec. 31, Herndon abandoned his previous plan in favor of mediation, saying this alternative will "better serve" plaintiffs and defendants in these cases. Herndon ordered both sides to meet with Saltzburg "without delay" and negotiate in good faith.
The order not only put the first Yaz trial—Kerry Sims v. Bayer—on hold, but also put the rest of the bellwether trials in limbo. Herndon is presiding over thousands of suits claiming Bayer contraceptives Yaz and Yasmin caused dangerous blood clots, and the drugmaker didn't adequately warn patients of the risks. Bayer maintains the pills are safe and effective when used as directed.
Lawyers aren't the only ones debating the drugs' safety. A range of studies have turned in conflicting results on their safety risks, with some highlighting substantial increase in clotting risks and others finding no increase. In December, an FDA advisory panel reviewed the data, and the group recommended labeling changes to clarify the potential risk of blood clots. The committee backed the drugs' risk-benefit profile, however, with a 15-11 vote.
- get Judge Herndon's order (PDF)