Bayer Acknowledges 70 Yaz Side Effect Lawsuit Settlements

Bayer has reportedly settled something in the neighborhood of 70 Yaz side effect lawsuits. The Yaz lawsuits were filed by women who allegedly suffered blood clots, deep vein thrombosis, pulmonary embolism, strokes and other serious complications due to their use of the Yaz birth control pill.

Yaz, along with a related contraceptive, Yasmin, have been named in more than 11,000 lawsuits alleging these and similar birth control pills caused users to suffer serious, life-threatening side effects including blood clots, strokes and gallbladder problems. Most of 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 David Herndon in the U.S. District Court for the Southern District of Illinois. Late last year, the first bellwether trials, or test cases, scheduled to start in that litigation were postponed indefinitely. Judge Herndon instead ordered the parties to begin settlement negotiations, and appointed a special master, George Washington law professor Stephen Saltzburg, to mediate.

According to the latest annual report filed by Bayer, the maker of Yaz and Yasmin, the company had reached 70 Yaz lawsuit settlements as of February 13, 2012. The terms of the settlements weren’t revealed, but Bayer admitted no fault.

Yaz, Yasmin and similar drugs involved in the litigation contain a synthetic form of progestin called drospirenone. In December, a panel of U.S. Food & Drug Administration (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 recommendation followed release of an FDA-funded study involving more than 800,000 American women using some form of hormonal birth control between 2001 and 2008. The study found that those taking pills with drospirenone were 75 percent more likely to experience clots compared to those taking other oral contraceptives. The FDA study was the fifth large study since 2009 to find 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 Bayer, have failed to find a higher risk.

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