Friday, September 18, 2009

Yaz Litigation

The FDA recently sent a warning letter to Bayer, which manufacturers Yaz and Yasmin (both types of birth control pills), that it has quality control problems at its German plant.  The FDA claims that Bayer's testing method averaged out the test results as opposed to reporting results for each batch.  Bayer had the batches shipped to the U.S. between 2007 and 2009.  

This news is simply the most recent concern about Yaz.  Litigation is already pending in Pennsylvania in front of Judge Sandra Mazer Moss of the Philadelphia Court of Common Pleas, alleging that the drug causes severe side effects including blood clots, strokes, heart attacks, gallbladder disease, deep vein thrombosis, pulmonary embolisms and even sudden death.  There has been some speculation around the internet that the FDA will recall the drug.  As the U.S. Recall News reports:

"In July 24, 2009, a petition was filed to consolidate the many lawsuits against Bayer over Yaz and Yasmin into a multidistrict litigation (MDL). There is a hearing scheduled for September 24, 2009 to decide whether or not they will be consolidated." 

"Andrew Gillin, an attorney handling several California Yaz lawsuits says the litigation is still in the early stages. “A petition has been filed to combine all of the federal lawsuits into a multi-district litigation (MDL) case. Later this month, a panel of federal judges will determine whether the cases involve sufficiently common questions of fact, and whether or not to consolidate,” explained Mr. Gillin."


FDA, Pharmaceuticals - Misc. | Permalink

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