Bayer Yasmin Trial Is Postponed For Mediation
January 6th, 2012 // 1:16 pm @ jmpickett
On the eve of the first trial in which Bayer faces accusations that it hid the risks of blood clots associated with its Yaz and Yasmin birth control pills, a federal judge has ordered that mediation should instead begin in hopes of reaching a settlement (here is the order).
The move comes after a month in which controversy over the contraceptives reached new levels. First, newly unsealed court documents in the sprawling litigation involving the Bayer drugs showed that former FDA commish David Kessler offered a scathing expert opinion that the drugmaker wrongfully withheld safety info from regulators (read his report here).
Then, an FDA advisory committee voted 21-to-5 to change the labeling for both pills to reflect a higher risk of blood clots. But the panel did not approve a warning that Yaz and Yasmin patients are more likely to develop blood clots than those using other birth control pills. An FDA study, meanwhile, had found a 74 percent increased risk of blood clots in women using contraceptives containing drospirenone, the main ingredient in the Bayer pills.
The 10,000-plus lawsuits allege Yaz and Yasmin have risks beyond those of traditional birth control pills and Bayer too aggressively promoted the pills without disclosing those higher risks. Earlier this year, a pair of studies found that women taking birth control pills containing drospirenone are more likely to develop blood clots than those who take an older oral contraceptive (see this and this).
Instead of the contentious battle playing out in court, US District Court Judge David Herndon appointed Stephen Saltzburg, a George Washington University law professor, as mediator. Earlier this year, Bayer protested that bellwether trials may not provide sufficient guidance on claims, Bloomberg News reported.
“Bayer didn’t want to go to trial and the judge decided to see whether they wanted to seek a solution outside the courtroom,†Michael Papantonio, an attorney who represents women who are suing the drugmaker and was scheduled to argue a case next week, tells the news service. “He’s giving both sides a chance to be creative.â€
