Trial or Settlement? 11,500 Yasmin and Yaz Lawsuits Hang in the Balance

Washington, DCIt remains unclear if lawsuits over Yaz side effects—and issues relating to its' close contraceptive cousin Yasmin birth control—will ever make it to trial, or if Yasmin / Yaz manufacturer Bayer Pharmaceuticals will be successful in negotiating settlements that will satisfy plaintiffs involved in more than 11,000 lawsuits.

The Yasmin / Yaz duo came onto the market with much fanfare. Bayer targeted the so-called third generation oral contraceptives to young women concerned about the potential for bloating and weight gain. Bayer claimed that Yasmin and Yaz could also mitigate acne and minimize PMS symptoms—a claim Bayer could not substantiate when challenged by the US Food and Drug Administration (FDA).

Nonetheless, Yasmin and Yaz quickly became a leader in the highly competitive contraceptive market, but not without cost: as more and more women adopted the use of the synthetic hormone drospirenone (the active ingredient in Yasmin / Yaz), reports of Yasmin blood clots and their sometimes horrific consequences began to escalate. There have been several deaths—many amongst very young women—together with other Yaz side effects that have resulted in blindness, stroke, heart attack, Yasmin gallbladder problems or complete incapacitation.

Critics of the Yasmin pill have decried the contraceptive for having a higher risk for DVT (deep vein thrombosis, or blood clot). That concern was supported by a Danish study published this past fall in the British Medical Journal (BMJ) that found a doubled risk for blood clots amongst the 1.3 million Danish women studied.

Bayer countered with a study—which Bayer funded—that appeared to show no increased cardiovascular risk when compared with other oral contraceptives.

Nonetheless, the FDA mandated Bayer and other manufacturers to beef up warnings on their labels. As for Yasmin and Yaz in particular—and all other oral contraceptives which contain drospirenone, warnings are required to state that researchers have found a blood clot risk that could go as high as three times that of traditional contraceptives.

So why the delay in trials?

It has been reported that the judge overseeing the Multi-District Litigation (MDL) for Yasmin and Yaz is encouraging the two camps to negotiate settlements, rather than going to trial. To that end, deadlines for lawsuits have reportedly been extended by Chief Judge David R. Herndon, of the US District Court for the Southern District of Illinois for 90 days, in order for settlement talks to continue.

In its annual report released in February, Bayer implied it had settled 70 cases related to Yasmin and DVT, and Yaz. That's but a small dent in a litigation portfolio that has swelled to more then 11,500 cases.

According to PR Newswire (5/2/12), Bayer has since agreed to fork out $142 million to settle 651 lawsuits related to Yaz side effects and Yasmin birth control. But there is much more work to be done.