Yaz Lawsuits on the Rise After FDA Strengthens Label Warning

The number of lawsuits from women alleging blood clots and other complications from Yaz has grown substantially in the wake of the stronger label warning ordered by the FDA in April 2012. A July 2012 statistics report from the U.S. Judicial Panel on Multidistrict Litigation stated that the number of lawsuits in the Yaz MDL had grown to 8,825 pending cases, making it the largest pending MDL in the United States.

The stronger label warning states that “some epidemiological studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products…whereas other epidemiological studies found no additional risk.”

FDA panel voted not to recall Yaz, despite known risk of blood clots

The strengthened Yaz label warning was the result of a December 2011 FDA advisory panel meeting at which the 26-member panel evaluated and discussed the evidence that Yaz causes blood clots, heard testimony on the issue, and debated whether the contraceptive should be recalled.

Despite an FDA study that found that women who took birth control pills with drospirenone (which is found in Yaz, Yasmin, and Ocella) had an increased risk of developing blood clots compared to women who took contraceptives without drospirenone, the FDA panel voted 15 to 11 to keep the controversial contraceptives on the market, deciding that the benefits of these contraceptives outweighed their risks. However, the panel additionally voted 21 to 5 to add a stronger warning to the contraceptives’ labels and specifically warn about the increased risk of blood clots.

On March 9, 2012, four women’s advocacy groups sent a joint letter to FDA Commissioner Margaret Hamburg protesting the decision to keep drospirenone-containing contraceptives on the market and stating that the decision put women’s lives in danger. The groups also complained that some of the studies the FDA looked at which did not find an increased blood clot risk were funded by Bayer or other contraceptive manufacturers, and thus were not objective or reliable.

Additionally, it was later revealed that four of the FDA panelists had previous ties to contraceptive manufacturers, which could be a conflict of interest. In January 2013, U.S. watchdog group the Project on Government Oversight asked the FDA to hold a new vote on whether to recall birth control pills with drospirenone.

Yaz litigation

As of October 2012, more than 12,400 Yaz lawsuits had been filed by women who claim to have suffered blood clots, stroke, pulmonary embolism, deep vein thrombosis, or other serious side effects of Yaz, Yasmin, or Ocella. In some cases, lawsuits have been brought by family members of women who died after using these contraceptives. The Yaz MDL was established in October 2009 to consolidate Yaz lawsuits in the Southern District of Illinois under U.S. District Judge David R. Herndon.