Lawsuits stemming from blood clots linked to birth-control pills Yasmin and Yaz have been settled by Bayer AG for more than $402 million to date, the company reported in a July 31, 2012, stockholders' newsletter.
The $402.6 million price tag is the result of settling about 1,900 cases in one category of clot cases, Bloomberg Businessweek reports. That's an average of $212,000 per case. In addition, the contraceptive manufacturer said it has $610.5 million set aside for Yaz cases, which is more than double its reserves in 2010 and 2011.
Blood Clots Can Be Deadly
When a prescription medicine causes blood clots, it is a serious concern because the clots can lead to irreversible conditions, such as heart attacks and strokes, that can be deadly. A study published in the British Medical Journal in October 2011 found that pills that contain the synthetic hormone drospirenone, such as Yaz and Yasmin, increase the risk of deep vein thrombosis (DVT) sixfold. DVT is the formation of clots in the leg that can travel to the lungs.
Bayer was facing more than 12,000 lawsuits over Yasmin and Yaz, with claims linking the contraceptives to blood clots and damaged gallbladders. Bayer has only agreed to settle cases that are linked to the clots.
“Such injuries are alleged in about 6,000 claims and therefore in fewer than half the cases served to date,” Bayer officials said in the newsletter.
In April, the U.S. Food and Drug Administration (FDA) ordered manufacturers of drugs that contain drospirenone to add warning labels about the increased risk of blood clots -- especially during the first year the medicine is taken.
Yaz Multidistrict Litigation
Bayer's settlements stem from a Yaz multidistrict litigation (MDL) underway in the U.S. District Court for the Southern District of Illinois. In an MDL, lawsuits with similar claims are consolidated to streamline the pre-trial discovery process. This means the evidence and testimony will be shared among the cases. However, each plaintiff retains the right to an individual trial with a separate judgment or monetary settlement.
In the Yaz MDL, Chief Judge David R. Herndon appointed George Washington School of Law professor Stephen Saltzburg to act as Special Master. In this role, Saltzburg mediates the cases and tries to help both sides settle without going to trial. Herndon has extended all court deadlines to facilitate this process.
Negotiations continue in the cases related to clots in the veins, but Bayer refuses to discuss those related to gallbladder injuries, paving the way for a bellwether trial. A bellwether trial is a test case in the MDL, allowing both sides to gauge how evidence and testimony will play out in court. Bellwether trials can help plaintiffs and defendants decide whether to settle future cases or take them to trial.