Bayer Yaz Patch Delay?

Reuters has reported on September 20, 2012 that the US application for a new birth control patch made by Bayer, the company that manufacters Yaz and Yasmin, will come after that to European nations.

Bayer’s Yaz Patch Delayed by FDA


Bayer may have hit another roadblock with the FDA over its birth control medications.  Bayer has decided to move slower in the US in the approval process for its new birth control patch, possibly out of concerns over blood clots that have plagued its similar medications Yaz and Yasmin for years.   Bayer’s product would offer an alternative to Johnson & Johnson’s Ortho Evra birth control patch, which is approved in North America and Europe.  However, US drug advisors have been recommending that the label of the J&J drug be simplified to better explain potential blood clot risks.  A potential delay in approval due to the warnings ongoing evaluation may have factored into Bayer’s slower application track.


In April, the FDA required Yaz and similar drugs to have stronger warning labels because of the seriousness of blood clots and the many issues blood clots may cause. Women taking Yaz have reported blood clot related illnesses such as pulmonary embolisms, strokes, deep vein thrombosis (DVT), kidney failure, and gall bladder infection and removal. Bayer’s birth control patch uses the same hormone as Yaz, drospirenone, and the FDA is delaying release of the patch over concerns about the warning label.


All of this activity comes more than a year after the FDA released its own study detailing the link between Yaz and blood clots entitled, “Combined Hormonal Contraceptives and the Risk of Cardiovascular Disease Endpoints”. (Click here for FDA study).


Multidistrict Lawsuit Pressures Bayer to Settle Come Yaz Lawsuits


This latest delay is not the only recent trouble for Bayer. Bayer is the subject of over 10,000 lawsuits nationwide from users of Yaz. A special multidistrict case has been set up in Illinois to deal with the huge volume of federal lawsuits against Bayer from across the nation. The full name of this case is Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100, Southern District Illinois). Click for multidistrict litigation webpage. According to court papers and reports to Bayer stockholders, Bayer had settled as many as 1,900 cases. Earlier this year, Bayer set aside additional funds to cover possible settlements and judgments. They have so far set aside $610 million.


With Bayer having paid out $402 million to settle 1,900 cases, they are paying on average  $212,000 per case. Bayer is only settling blood clot cases at this time. Some news outlets are speculating that the Yaz litigation may cost Bayer as much as $1.2 billion. If you or someone you love has taken Yaz and has had symptoms of Yaz blood clots, Yaz pulmonary embolisms, Yaz strokes or Yaz DVT, time may be limited to enforce your legal rights.  The lawyers of Slater Slater Schulman LLP are here to help. Please call us to discuss your potential Yaz lawsuit at 1-800-251-6990 or fill out the form on the right of this page and someone from our office will contact you to discuss your case.

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