Yaz MDL Grows To Largest In The Country
On May 31, 2012, the Institute for Safe Medication Practices released their “annual report issue” of QuarterWatch, an independent publication that monitors all domestic, serious adverse drug events reported to the FDA.
According to the publication, Yaz/Yasmin birth control pills were named in more lawsuits in 2011 than any other medication except the heartburn drug, Reglan (metoclopramide). These drugs, which contain the so-called “fourth-generation” progestin drospirenone, have been linked with blood clots and related complications like Yaz deep vein thrombosis and Yaz stroke.
“Combined oral contraceptives containing drospirenone acquired strong new FDA warnings about increased risk of blood clots,” stated the report, “but were not withdrawn even though safer alternatives with lower risk are available.”
Yaz lawyers are currently representing thousands of plaintiffs nationwide in cases against manufacturer Bayer, with the majority of these proceeding in the Yaz MDL in the Southern District of Illinois, which recently became the largest MDL in the country.
Yaz lawyers accuse Bayer of over-promotion
The FDA approved Yasmin in 2001 and Yaz in 2006, both for use as oral contraceptives. Early marketing programs over-promoted the benefits of the medications, leading women to believe they would not only prevent pregnancy, but ease symptoms of premenstrual syndrome (PMS) and acne. The FDA sent warning letters to the company and required them to air corrective commercials. Yaz lawyers have noted this chain of events when presenting evidence in lawsuits.
Reports of problems with the medications started coming into the FDA in 2004, and included blood clots, Yaz deep vein thrombosis, pulmonary embolism, and stroke. Some of these problems were occurring in young women as young as 17 years old.
FDA warns of Yaz deep vein thrombosis
On April 10, 2012, the FDA stated that new warnings about the risk of blood clots will be required on the labels of birth control pills that contain drospirenone. The agency made the decision after reviewing recent studies that showed the pills could be associated with an increased risk of blood clots.
The revised drug labels report that some epidemiologic studies showed as high as a three-fold increase in risk of blood clots for drospirenone-containing products when compared to products containing other progestins, like levonorgestrel.
Yaz MDL surpasses asbestos consolidation
Meanwhile, Yaz lawyers are busy negotiating settlements with Bayer in the Yaz and Yasmin MDL. According to the U.S. Judicial Panel on Multidistrict Litigation, as of July 2012, a total of 8,825 federal actions were pending in the MDL. With the increased filings since then, Yaz and Yasmin litigation has surpassed the asbestos MDL, pending in the Eastern District of Pennsylvania, to become the largest MDL in the country.
As of July 19, 2012, Bayer had negotiated settlements for 1,877 U.S. Yaz lawsuits, for a total of $402.6 million. The company plans to continue settlement negotiations with plaintiffs’ Yaz lawyers, with an estimated eventual cost of $1.2 billion.