January 28, 2013 – UPDATE
In a Press Release, the European Medicines Agency, announced that it would review 3rd and 4th Generation Combined Oral Contraceptives over safety concerns and the risk of blood clots. We previously noted that this was a developing trend in Europe as thousands of YAZ LAWSUITS remain pending in the United States.
The PRESS RELEASE, entitled “European Medicines Agency to Review 3rd & 4th Generation Combined Oral Contraceptives, Review to Determine Whether Changes to Authorisation are Necessary“, presents a global threat to BAYER’s troubled contraceptive legacy. Our prior post, below, explains more. This recent development means enough countries questioned existing data over the risk of blood clots across the European Union. Ponder that as thousands of cases remain unresolved in the United States over blood clot risks.
Recent reports from France & Switzerland, indicate that the embattled line of YAZ, YASMIN, BEYAZ & SAFYRAL, birth control pills are under even more scrutiny by health authorities in both countries, as well as the European Medicines Agency (EMA). As we have previously posted here, BAYER HEALTH CARE PHARMACEUTICALS is the manufacturer of the DROSPIRENONE (DRSP) containing family of contraceptives in the United States. Extensive information on still pending litigation and ongoing settlements is available at DRSPRecall and YAZRecall.
On January 3, 2013, REUTERS reported, in “FRANCE MAY CURB USE OF RISKIER ORAL CONTRACEPTIVES“, that French health regulators were considering, and studying, limiting the use of birth control pills that carry higher health risks. Citing the European Medicines Agency (EMA), REUTERS noted that:
The European Medicines Agency says the risk of an embolism, or blood clot, is twice (2x) as high for women using third and fourth-generation pills than for those using earlier versions, although it remains low. The risk of a stroke is the same.
France’s health ministry has cut off reimbursement for certain pills folowing a lawsuit against BAYER and a French Official. The cut off is scheduled for March 31, 2013. The lawsuit, involving Marion Larat, involved a third generation pill, marketed as Meliane which left the 25 year old partially paralyzed.
Disclosure of higher risks and warning girls and women that they were undertaking a higher risk is at the heart of thousands of pending lawsuits over the DROSPIRENONE family of contraceptives in the United States.
Subsequently, on January 11, 2013, REUTERS reported that “France Will Ask EU to Curb Use of Newer Birth Control Pills“. The story, by Elena Berton reported that French Health Authorities, including the head of France’s health regulator, Dominique Maraninchi, would be asking the European Union to modify prescription guidelines certain birth control pills. While not mentioned by name, manufacturer or tradmark, BAYER’s DROSPIRENONE (DRSP) containing pills fall in the catergory pills subject to restricted guidelines. It is estimated that some 2.5 Million women in France take 3rd or 4th Generation birth control pills that are subject to the more restrictive guidelines. Whether this scrutiny over novel hormones by health authorities will be limited to Europe, or will regain traction in the United States, is something we intend to monitor carefully.
On January 9, 2013, REUTERS reported, in “SWISS HEALTH INSURER MAKES CLAIM AGAINST BAYER OVER YASMIN PILL“, that Switzerland’s largest health insurer is joining a pending lawsuit against BAYER. Reportedly, the insurer, CSS, is acting as a joint Plaintiff in prosecuting an action for medical bills following a Pulmonary Embolism, or blood clot in the lung(s). The story noted that the young woman suffered a pulmonary embolism a few weeks after being prescribed the pills and was left severely disabled.
In light of developments in Europe, it is arguable that the U.S. Food & Drug Administration (FDA) and may need to revisit their past scrutiny and lack of more aggressive action regarding the DROSPIRENONE line of contraceptives. While the ‘warnings’ that come with the popular contraceptives have been amended – several times – to communicate risks it is possible this has been a failed effort that continues to put young girls and women at risk.
A controversial Advisory Committee consider a ‘market withdrawal’, or ‘recall’, and the DROSPIRENONE family of pills narrowly survived a vote. However, investigative reports revealed that a number of voting members had financial ties to the manufacturer, raising questions about the entire process and adding to confusion regarding FDA’s role in policing the brand of contraceptives.
The manufacturer, BAYER, continues to face thousands of pending lawsuits in the United States. While there have been reported settlements, and agreements to settle thousands of cases, with payments expected to exceed $1 Billion U.S. Dollars, thousands of cases remain pending. BAYER has been evaluating cases on a case by case basis for nearly a year. All the while continuing to market and sell the controversial line of DROSPIRENONE pills. Could developments in Europe portend an ominous end for the pills? Time will tell.
Our office continues to investigate and accept cases involving blood clots and the Blockbuster DROSPIRENONE family of contraceptives.