Bayer AG, the maker of Yaz and Yasmin birth control pills, has agreed to settle roughly 500 lawsuits alleging the contraceptives caused serious blood clots, some of which led to heart attacks and strokes. According to Bloomberg News, the settlements will cost Bayer roughly $110 million, or $220,000 per case.
Yaz, Yasmin Lawsuit Background
Some 11,000 plaintiffs have filed suit against Bayer alleging that Yaz and Yasmin and similar birth control pills caused a number of serious side effects, including:
- Blood clots
- Deep Vein Thrombosis
- Pulmonary Embolism
- Heart Attacks
- Gallbladder problem
The majority of those cases are being overseen by Judge David Herndon in a multidistrict litigation currently underway 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, at the behest of Bayer, instead ordered the parties to begin settlement negotiations, and appointed a special master, George Washington law professor Stephen Saltzburg, to mediate.
Bayer Yaz and Yasmin Lawsit Settlements
Bloomberg is reporting that the 500 Yaz and Yasmin lawsuit settlements were confirmed by two anonymous sources close to the litigation, though they have yet to be announced publicly. “Bayer HealthCare confirms that some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled,” Rosemarie Yancosek, a U.S. spokeswoman for the drugmaker, said in a statement emailed to Bloomberg. However, there was no confirmation on the number of settlements or their amounts.
This isn’t the first time settlements of Yaz and Yasmin lawsuits have been confirmed by Bayer. As we reported previously, Bayer revealed in its Annual Report issued in February that it had settled somewhere in the neighborhood of 70 Yaz and Yasmin lawsuits filed by women who allegedly suffered blood clots, deep vein thrombosis, pulmonary embolism, strokes and other serious complications due to their use of the medications. Bayer did not reveal the terms of the settlements, nor did it admit any fault.
New Yaz, Yasmin FDA Blood Clot Warnings
News of the Yaz and Yasmin settlements come just days after the U.S. Food & Drug Administration (FDA) announced that the labels for those contraceptives, as well as others that also contain the synthetic progestin, drospirenone, would be updated to provide more information regarding their blood clot risks. In a Drug Safety Communication issued Tuesday, the FDA said it had completed its review of studies that assessed the association between drospirenone birth control pills and blood clots, and had determined that these drugs might pose a higher clot risk than oral contraceptives made with other progestins. The new label information will state that some of the studies reviewed by the FDA reported as high as a three-fold increase in the risk of blood clots, whereas other studies found no additional risk of blood clots with drospirenone-containing products. The new label information will also include a summary of the previously released results of an FDA-funded study of the blood clot risk. That study, released last fall, found that drospirenone-containing birth control pills were associated with a 1.5-fold increase in the risk of blood clots, compared to those made with other progestins, the FDA said.