Yaz & Yasmin Lawyers & Settlements

More On the updated yaz warnings

Lawyers Weekly USA reported on April 18th about the updates warnings the FDA is requiring for the birth control pills Yaz and Yasmin.  The article reports that some studies have shown a threefold risk of developing blood clots while taking Yaz.  Partially as a result of those studies, the FDA now states that “[h]ealth care professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.”  Drospirenone is one of the ingredients in Yaz, and is a synthetic version of the hormone progesterone.

The article also points out that Bayer has already settled 70 out of approximately 11,300 Yaz lawsuits currently pending. 

More Coverage on the new FDA warning for yaz

The April 12th edition of the International Business Times News has an article entitled “Birth Control Pills Get New FDA Warning.”  That article discusses the new FDA warning for Yaz, Yasmin, and other birth control drugs that contain the synthetic hormone drospirenone.  The article explains that the risk of blood clots is increased when using these drugs:

For every 10,000 women who are not pregnant and do not use the pill, between one and five will develop a blood clot, the FDA said. Between three and nine out of every 10,000 women who use contraceptives will develop a blood clot, and between 40 and 65 women out of 10,000 will develop a blood clot within 12 weeks of giving birth, the organization said.

The article notes that depending upon the brand of birth control pills used, a woman could be three times as likely to develop a clot.  Most Yaz lawsuits also allege that Yaz increases a woman’s risk of developing a blood clot, a DVT, or a pulmonary embolism. 

Yaz lawyers like our firm are accepting cases from any woman who suffered a clotting-related injury while taking Yaz or Yasmin.  We can be reached at 888-315-3997.

FDA Panel votes 21-5 in favor of stronger warnings for yaz

On December 8th, an FDA panel reviewed six conflicting studies of Yaz.  Some of the studies (especially the ones funded by Bayer) found no increased risk of developing a blood clot with Yaz compared to other pills.  But other studies did find an increased risk – as high as a threefold increase in some cases.

The FDA panel voted 21-5 in favor of increasing the strength of the warnings on the Yaz package insert regarding the risk of blood clots and other injuries.  Because this is the federal government we’re talking about, it will be several months before the new warnings are actually approved and distributed. 

former fDA comissioner alleges that bayer hid safety data

Drug Industry Daily reported on December 7th that David Kessler, a former FDA commissioner alleged that Bayer purposely hid safety information about Yaz from the FDA.  More specifically, Kessler alleges that Bayer:

Declared in 2003 in advance of its analysis there was no increased risk of VTEs;

Failed to disclose that its own analysis revealed in 2004 an increased rate of VTEs compared to other oral contraceptives;

Presented selective views that obscured risks posed by Yasmin and Yaz; and

Failed to disclose data showing higher incidence of VTE with drospirenone compared to levonorgestrel.

Those are serious allegations.  If true, they could support an award of punitive damages against Bayer in the thousands of Yaz lawsuits currently pending.  Kessler also argues that the information purportedly hidden by Bayer could have delayed or derailed the approval of Yaz:

“Kessler wrote that if he knew of the adverse events prior to Yasmin's approval "I would have sought to investigate what was known or knowable about the incidence of serious adverse events, and would not have moved forward on a decision on NDA approval until such time as the results of the investigation were completed."

Yaz and Yasmin were both approved by the FDA in 2006.  Since then, thousands of women have developed DVT’s or had pulmonary embolisms while taking the drug.