On Friday, Bayer issued a press release announcing the label update for Yaz and Yasmin. The release stated:
“The updated labels confirm that the body of evidence continues to support that the relative risk of developing venous thromboembolism (VTE) in YAZ and Yasmin users is comparable to that of other combination oral contraceptive preparations, including those containing levonorgestrel. The labels also state, unchanged, that there is a risk of VTE among all combination oral contraceptives (a class effect), and provides additional information and context about data specific to drospirenone containing oral contraceptives.”
Bayer's
press release continues:
"The new information is based on two large, multiyear studies of more than 120,000 women taking contraceptives in the U.S. and the U.K., Bayer said.
• With regard to the case-control study, the label indicates that, “…the number of Yasmin cases
was very small (1.2% of all cases) making the risk estimates unreliable.”
• Concerning the retrospective cohort study, the label indicates that, “The relative risk for
Yasmin users in the retrospective cohort study was greater than that for users of other COCs
when considering women who used the products for less than one year. However, these one year estimates may not be reliable because the analysis may include women of varying risk
levels. Among women who used the product for one to four years, the relative risk was similar
for users of Yasmin to that for users of other COCs.”
These claims represent a desperate effort at spin by Bayer to avoid responsibility. Bayer wants to continue to rake in profits while limiting its risk. However if you carefully read what they are saying, the facts simply confirm that the many lawsuits and claims have strong merit.
First Bayer claims that risks between 2nd generation and DRSP based COC's are "comparable." Well, certainly they can be compared. And when you do compare the risks, it is clear that the 2nd generation pills have a much lower risk!
They then denigrate the recent studies because of the large number of injuries to women taking Yaz within the first year. In other words, Bayer wants to ignore the women who were injured in the first year of taking Yaz. This is when most of our client's suffered their injuries and death. It is precisely these women who are most at risk. The addition of the Yaz / Yasmin / Ocella DRSP to their systems throws off the balance of hemostasis and generates the clot that can kill. It is simple science.
But as long as Bayer continues to see the opportunity for profits over people, it will continue to market market market. And critically, Bayer has still failed to acknowledge the huge risk of injury from gall bladder disease posed by Yaz. The misleading way in which Bayer wrote the press release suggests that the FDA agreed with Bayer's analysis of the studies. The FDA has not performed its own analysis. It simply consented to the label change.
While some may believe these modest acknowledgments of increased risk are sufficient to protect Bayer from future lawsuits, in my opinion they do nothing to limit future liability of Bayer, even for those women who consume the pills after the revised label.
If you or a loved one have suffered a DVT, Pulmonary Embolism (PE), stroke or gall bladder disease after taking Yaz you should immediately get legal assistance. You can call us toll free at 888-841-9623 or send an email to our dedicated Yaz paralegal, Malina, malina@toledolaw.com. We are proud to represent over 300 victims of Yaz nationwide in the courts of the MDL, Pennsylvania and New Jersey and look forward to bringing Bayer to justice on their behalf.
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