File this under ‘what a surprise!’ Three months after a federal judge ordered mediation for Bayer and lawyers representing thousands of women who claim the Yaz and Yasmin birth control pills cause sometimes fatal blood clots (back story), the drugmaker has agreed to settle 500 lawsuits for about $110 million. Lawyers involved in the sprawling litigation against Bayer have cited FDA reports of at least 50 deaths tied to the pills between 2004 to 2008.
Although some 11,300 lawsuits are still lodged in courts around the US, an effort to settle some cases was predictable. The move, which was first reported by Bloomberg News, comes just as the FDA had Bayer upgrade the product labeling for both pills to reflect the increased risk of blood clots (back story). This change may, in fact, prompt still more lawsuits. A Bayer spokeswoman confirms that some lawsuits are being settled, but would not comment further.
The 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. Last year, a pair of studies found that women taking birth control pills containing drospirenone – the active ingredient in the Bayer pills – are more likely to develop blood clots than those who take an older oral contraceptive (see this and this).
Late last year, 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.
However, the FDA has since been widely criticized for its handling of the committee meeting. Before the gathering, the FDA yanked Sid Wolfe of the Public Citizen Health Research group from the panel due to an intellectual conflict of interest (read here). Afterwards, concerns were raised because four panel members held ties to Bayer, either as paid consultants or in the form of research funding, but the FDA did not disclose the conflicts, prompting the Project on Government Oversight, a watchdog group, to ask the FDA to convene an entirely new meeting (read this and this).
handshake pic thx to o5com on flickr