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Yaz, Yasmin Blood Clot Risk Cited in Thousands of Personal Injury Lawsuits

by lchiu89 on September 27, 2012

 

Overview: Yaz and Yasmin birth control pills were highly popular and heavily advertised when they first hit the market, but now the oral contraceptives are making headlines over reports that they may cause deadly blood clots. There are some 12,000 Yaz or Yasmin personal injury lawsuits in US, and only a fraction have been settled so far. The majority of cases are pending in the multidistrict litigation in U.S. District Court for the Southern District of Illinois centralized before Judge David R. Herndon (MDL No. 2100).

David Kessler, former commissioner of the U.S. Food and Drug Administration (FDA) is one the people who have supported the allegations against Bayer. Last year, he issued a report stating that “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from pre-marketing to the present.”

Drospirenone-Based Birth Control Associated with Blood Clots, Related Disorders

Yaz and Yasmin were approved in 2001 and 2006, respectively. They are two very similar types of oral contraceptives. The only difference is that Yasmin’s regimen has 21 days of active pills while Yaz has 24 days. Both birth control pills contain drospirenone, a chemical that has been linked to an increased risk of blood clots. Oftentimes, the blood clot can form in the deep veins of the leg in a condition known as deep vein thrombosis. When this happens, there is a risk that a piece of the blood clot will break off and become lodged in the lungs; this is called a pulmonary embolism (PE). Since they often occur together, DVT and PE are collectively referred to as venous thromboembolism.

Last April, the British Medical Journal published a study showing that women who use drospirenone-based birth control pills like Yaz or Yasmin may have triple the risk of experiencing non-fatal venous thromboembolism. Approximately one year later, the FDA updated the safety label on Yaz, Yasmin and other birth control pills containing drospirenone to warn about the potential risk of blood clots and blood clot-related disorders.

Settlements

So far, Bayer has settled about 1,900 Yaz and Yasmin cases for $402.6 million (approximately $212,000 per case). At this rate, the company estimates that it may spend up to $1.2 billion on the litigation. Bayer has also doubled its reserves for Yaz suits by setting aside $610.5 million in anticipation of potential settlements.

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