Yaz is a fourth-generation oral contraceptive, and since it came on the market has been found to come with serious potential complications. The most important of these are blood clots that can cause a heart attack or stroke and leave women either permanently damaged or even dead. Yaz was developed, manufactured, and sold by Bayer and is used to prevent pregnancy, but also to treat premenstrual dysphoric disorder, acne, and irregular menstrual cycles.
In some ways Yaz is just like older types of oral contraceptives in that it contains two types of synthetic hormones that prevent pregnancy. One of these, though, is a newer formulation and can cause debilitating and life-threatening complications. Women who suffered because of taking Yaz feel as if they were misled by Bayer’s marketing and that they were not adequately warned of the risks. This has led to thousands of Yaz lawsuits and millions of dollars in settlements.
What is Yaz?
Like many other oral contraceptives, Yaz includes ethinyl estradiol, a synthetic estrogen as well as a synthetic progestin. Together these two synthetic hormones prevent ovulation, change the lining of the uterus, and make it difficult for sperm to survive long enough to fertilize an egg. They are very effective at preventing pregnancy when taken as directed with no mistakes. What makes Yaz a fourth generation oral contraceptive, and different from older contraceptives, is a new synthetic progestin called drospirenone.
Bayer developed Yaz by creating this new progestin and first received approval for it from the U.S. Food and Drug Administration (FDA) in 2001. One positive thing about drospirenone is that it was found provide more benefits than just preventing pregnancy. It also clears up acne in many women and can relieve the symptoms of premenstrual dysphoric disorder, a premenstrual syndrome characterized by severe mood swings, depression, irritability, and physical symptoms. The FDA only approved Yaz for these conditions in women who were already planning to use an oral contraceptive to prevent pregnancy.
Aggressive Marketing Tactics
When Bayer received approval for Yaz in 2001 it went all out in marketing and advertising the latest birth control and what it could do for skin and moodiness. The FDA has specific rules about how drug companies can market their products and Bayer pushed the boundaries, and according to plaintiffs in the lawsuits against the company, went way past those boundaries.
The advertising for Yaz was aggressive and played up the fact that it can relieve acne and premenstrual dysphoric disorder. While playing up the benefits, which were only available to those women looking for birth control, Bayer also downplayed risks associated with taking Yaz. The FDA warned Bayer that its advertisements were misleading and that they suggested to women that Yaz could treat mild acne and ordinary PMS symptoms, when really it was only supposed to treat moderate acne and serious premenstrual dysphoric disorder.
The FDA even criticized Bayer for using visual effects and music to distract the target audience from the disclosure of risks. Bayer may have included the risks of Yaz in its advertising, something it was technically required to do, but it did its best to make sure viewers didn’t notice them, a violation of FDA rules. Bayer changed its advertising of Yaz after receiving the warning, but controversy has continued to swirl over just how risky Yaz is and how the company failed to warn women.
Yaz and Blood Clots
The main reason Yaz is risky is that it can cause blood clots. This is what Bayer tried so hard to hide from consumers and what led to the thousands of lawsuits the company has faced and is still facing. Blood clots typically form in the legs, but from there they can move to the heart, lungs, and brain, causing dangerous blockages. Blood clots can quickly kill someone with little warning or cause a stroke that has long-term and debilitating consequences.
Yaz is known now to increase the risk of developing a blood clot, and yet the warning about this risk from the FDA did not come out until 2011. With ten years on the market, Yaz caused a lot of harm to unsuspecting women who thought they were taking a safe birth control with the bonus that it would lead to clear skin and less moodiness.
Studies have been very clear about the risk. The FDA funded some of this research, which found that the risk of forming a blood clot while on Yaz was increased 1.5 times as compared to women not using the drug. Although the FDA made a preliminary warning about this in 2011, it waited for more information from studies to officially require that Bayer change the Yaz label. The new label information included that some studies found the risk to be three times as great that a woman on Yaz would develop a dangerous blood clot.
Lawsuit Claims
Thousands of women have filed Yaz lawsuits against Bayer making various claims. Some of these include the fact that Bayer marketed and advertised Yaz in a way that was deliberately misleading. Because the FDA warned Bayer about this, many women have a good case to make. They were intentionally misled to believe that Yaz was safer than it is in reality.
Plaintiffs are also accusing Bayer of not testing Yaz adequately in clinical trials and failing to adequately warn consumers about the risks of blood clots. Many have also called for a recall of Yaz and claim that Bayer has been negligent in not doing so, considering that women have died because of using it. Additional claims made by plaintiffs include negligence, product liability, concealment fraud, misrepresentation of a medical product, and negligent medical monitoring.
Yaz Settlements
The Lawsuits against Bayer really started to proliferate after the FDA issued its warnings and required labeling changes for Yaz. By 2013 Bayer had already settled nearly 7,000 claims to the tune of $1.4 billion. By 2015 the company had settled another set of cases for nearly $60 million. The amount that goes to each plaintiff varies, but Bayer is not likely to be done paying out. There are expected to be more cases and more settlements reached in the future.
Do You Have a Yaz Claim?
If you took Yaz and suffered because of a blood clot or other serious complication, you may be able to make a case and file a lawsuit against Bayer to seek compensation. If you lost a loved one to Yaz, you also may be in a position to seek damages and to force Bayer to pay for your loss. Thousands of women have already successfully made the case that Bayer behaved in a way that was unethical if not illegal. The company actively and deliberately misled women into believing that Yaz was safe and that it could do more for them than simply prevent pregnancy.
Filing a claim can be complicated, but if you have a lawyer to represent you and guide you, taking the next step is possible. Find the right professional to give you the advice you need and to help you decide if you have a case to make against Bayer. Getting the compensation you are owed for your pain and suffering won’t undo the past, but it can make the future easier.
Sources
- http://www.fda.gov/Drugs/DrugSafety/ucm257164.htm
- http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm
- http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf
- http://www.cbc.ca/news/canada/british-columbia/yaz-yasmin-birth-control-pills-suspected-in-23-deaths-1.1302473
- http://www.bloomberg.com/news/articles/2012-07-31/bayer-s-yasmin-lawsuit-settlements-rise-to-402-6-million
- http://articles.chicagotribune.com/2013-09-15/health/ct-met-birth-control-risks-20130915_1_drospirenone-clots-pills