Edelman, Krasin & Jaye are leading product liability lawyers who have been following developments in Yaz litigation since the earliest adverse event reports began going public. Since then, we’ve seen the medication gain unprecedented popularity among young women who continue to using the contraceptive despite documented health risks. Compensation is available to those who have suffered side effects from Yaz, particularly blood clots, pulmonary embolism, and dvt.
A new millennium, a new birth control
In 2001, the U.S. Food and Drug Administration approved a new brand of birth control, Yasmin, that was manufactured by Berlex Laboratories, which later became Bayer Pharmaceuticals. Bayer aggressively marketed Yasmin, prompting the FDA to issue a warning about misleading advertisements in 2003. Despite the FDA’s concerns about Bayer’s advertising, in 2006 the FDA approved a contraceptive pill called Yaz that had the same primary active ingredient as Yasmin. After additional FDA actions in 2006 and 2007, Yaz became the first ever birth control pill approved not just to prevent pregnancy but also to treat premenstrual dysphoric disorder (PMDD) and moderate acne.
Bayer continued to market Yaz to young women, and Yaz quickly became a top seller. Unfortunately, many reports of problems began to surface. The new form of synthetic progesterone used in Yaz and in other medications called “fourth generation” birth control pills was allegedly turning out to cause very serious health issues.
Today, these health issues have affected thousands of women, causing serious injuries or even death. More than 11,300 product liability claims had been filed for Yaz side effects by February of 2012, and Bayer announced in its third-quarter report in September of 2013 that the company had paid out $1.6 billion to settle claims, while many cases still remain pending.
Women who suffered harm because of Yaz, Yasmin or a generic version of the medication called Ocella may be eligible to pursue a claim for compensation for their losses.
FDA warns of misleading advertising
When the Food and Drug Administration issued its first warning to Bayer Pharmaceuticals in 2003, the FDA indicated that “Yasmin can exacerbate serious heart and health problems,” and that Berlex Laboratories had direct-to-consumer advertising that overstated benefits and downplayed risks. The advertising was found to be “misleading and in violation of the Federal Food, Drug, and Cosmetic Act (Act) and applicable implementing regulations.”
The FDA warned Bayer of misleading television ads again in 2008. In 2009, the FDA cited Bayer for sponsored Internet ads that seemed to suggest the drug as a PMS treatment, and that failed to mention serious side effects. Following the FDA’s 2009 warning, Bayer spent $20 million on public advertisements to correct the misconceptions the company had created.
For many women, however, Bayer’s new corrective marketing came well after they had already begun the use of Yaz or Yasmin.
In both 2008 and in 2009, Yaz was the best selling birth control on the U.S. market. The popularity of the medication could partially be explained by the fact that Yaz had different cycling than other birth control pills on the market. While most birth control medications involved taking 21 active pills and then a placebo to make menstruation possible, Yaz instead established a schedule of 24 active pills. It was this new cycling that Bayer cited as a potential method of stopping PMS symptoms.
The new cycling of Yaz, however, was not what allegedly caused women so many problems. Instead, Yaz side effects reportedly stem from the use of the new form of synthetic progesterone called drospirenone.
Side effects of Yaz
Yaz, Yasmin and Ocella, all of which contain drospirenone, have all caused many women to experience dangerous or unexpected side effects.
Yaz and Yasmin side effects include:
- Thromboembolism: In 2011, the FDA reported that preliminary testing revealed a patient taking Yaz could experience as much as a 1.5-fold increase in the risk of blood clots as compared with patients on other birth control medications. While most birth control users have a 10 in 10,000 risk of blood clots, six out of 10,000 women taking Yaz would develop a blood clot. A 2012 study in the Journal of Contraception found a 77 percent increased risk of blood clots among Yaz users. The FDA ordered an update of labels on Yaz and Yasmin in 2012 to alert users that they were three-times as likely to get a blood clot than women using other oral contraceptives.
- Stroke: The same Journal of Contraception study that warned of an increased blood clot risk also indicated that women who used Yasmin or Yaz were twice as likely to have a stroke as women who relied on other methods of birth control pills.
- Gallbladder disease: According to a study published in April of 2011 in the Canadian Medical Association journal, women taking Yaz, Yasmin or Ocella had a 20 percent increased risk of gall bladder disease. For women who took Yaz for more than two years, there was a 30 percent increased chance that removal of the gallbladder would become necessary.
Not all side effects of Yaz are considered as serious, though patients taking any drug should be aware of all symptoms related to their medication.
For example, Yaz has been linked to health concerns such as:
- Unusual vaginal discharge
- Irregular menstrual bleeding
- Upper respiratory infections
- Pain in the breasts
- Nausea or diarrhea
- Yeast infection
- Severe allergic reaction
Yaz has settled some claims brought by patients experiencing these or other complications.
Yaz and yasmin settlements include:
- Bayer settled 70 lawsuits in February of 2012 that arose from claims that Yasmin was the cause of injury and/or death.
- Bayer paid $110 million in April of 2012 to settle around 500 claims that arose as a result of fatal blood clots.
- Bayer paid $1 billion in 2013 to settle around 4,800 cases involving injuries due to blood clots. The company also set aside $24 million for patients with gallbladder disease.
With the multiple settlements, estimates indicate that Bayer Pharmaceuticals has spent as much as $1.575 billion to resolve around 7,660 lawsuits arising from Yaz products. However, court records indicate as many as 9,873 Yaz claims still pending despite settlements.
In October of 2009, the Judicial Panel on Multidistrict Litigation (JPML) moved to have Yaz lawsuits consolidated in federal court in Illinois. A multidistrict litigation before one judge allows individual plaintiffs to retain separate claims while the judge rules on issues relevant to all cases.
Find a Yaz lawyer
Plaintiffs who wish to take action against Bayer should carefully consider their options to determine how best to make a claim. Speak with an experienced products liability and/or personal injury attorney who can advise you and your loved ones on the best course of action.
The product liability lawyers at Edelman, Krasin & Jaye has a long track record of handling complex product liability claims, so give us a call or contact us online today to learn how we can help with your Yaz lawsuit in New York City, Long Island or surrounding areas.
- Bayer Pharmaceuticals, Stockholdrs’ Newsletter Third Quarter 2013, http://www.stockholders-newsletter-q3-2013.bayer.com
- U.S. Food and Drug Administration, FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone, http://www.fda.gov/drugs/drugsafety/ucm299305.htm
- U.S. Food and Drug Administration, Yaz (drospirenone/ethinyl estradiol) tablets, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm249859.htm
- Department of Health & Human Services, NDA 21-098/ Yasmin, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
- Bloomberg, Bayer Said to Pay $110 Million in Yaz Birth-Control Cases, http://www.bloomberg.com/news/2012-04-13/bayer-said-to-pay-110-million-in-yaz-birth-control-cases.html