In April 2010, the U.S. Food & Drug Administration (FDA) approved Gianvi - a generic version of Bayer’s blockbuster birth control pill Yaz - to be sold in the United States by Teva Pharmaceuticals and Barr Laboratories. Litigation between Bayer and Teva/Barr for Gianvi patent infringement was settled later that year. Since then, Bayer has continued to manufacture Gianvi for the companies.
Gianvi contains drospirenone and ethinyl estradiol to prevent ovulation and cause changes in the cervical lining that make it harder for a fertilized egg to attach itself to the uterus. In addition to being used to prevent pregnancy, Gianvi is also commonly prescribed to treat moderate acne and premenstrual dysphoric disorder (PMDD) in females who are at least 14 years old and have started having menstrual periods.
Unfortunately, the drospirenone contained in Gianvi has the potential to increase potassium levels in the blood, which can lead to a number of serious side effects including:
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Heart Attacks
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Cardiac Arrhythmias
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Strokes
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Blood Clots
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Pulmonary Embolism (PE)
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Venous Thromboembolism (VTE)
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Deep Vein Thrombosis (DVT)
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Kidney Failure
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Seizures
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Gallbladder Disease
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Hepatic Adenoma
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Sudden Death
Many former Gianvi users who suffered from these adverse events were informed by lawyers and others that they cannot file lawsuits against Teva or Barr because of a legal defense known as ‘federal preemption.’ Specifically, in the 2011 case of Pliva, Inc., et al. v. Mensing, the U.S. Supreme Court ruled in favor of the generic drug company and against the injured patient such that any "failure to warn" lawsuit involving a generic drug would be dismissed.
However, as it turns out, there may still be legal recourse available for women who experienced serious Gianvi side effects because Bayer continues to manufacture the drug, and may share some of the legal liability for personal injury lawsuits involving Gianvi. This is a similar agreement to the one Bayer has with Teva and Barr with regards to Ocella, which Bayer makes for those companies, as well.
Bayer is currently facing thousands of lawsuits nationwide filed on behalf of women allegedly injured by Yaz, Yasmin, Ocella, Beyaz and Gianvi. Pursuant to agreements in 2008 and 2010, Bayer continues to manage product liability litigation for Gianvi. Defective drug lawyers around the country are currently investigating claims of a potential Gianvi lawsuit for any woman who developed serious side effects like blood clots or gallbladder disease after taking the drug.
Michael E. Schmidt is recognized as one of Americaʼs most passionate, accomplished and skilled trial lawyers. His law firm, Schmidt & Clark, LLP and The Senators Firm, LLP are currently accepting Gianvi lawsuits in all 50 states. To learn more about this topic, please visit his website: http://www.schmidtandclark.com/gianvi
