Bayer Pharmaceuticals has paid over $1 billion to settle lawsuits for blood clots, stroke and other life-threatening complications caused by Yaz and Yasmin birth control pills.
Yaz and Yasmin Lawsuit
Yaz was once the most popular oral contraceptive in the United States, bringing in well over $2 billion per year for manufacturer, Bayer Healthcare. Yaz and its sister drug, Yasmin, both contain the synthetic progesterone, drospirenone, along with ethinyl estradiol. Drospirenone is also one of the main ingredients in other birth control pills including Ocella and has been found to increase the risk of blood clot formation and other serious complications, some of which may be life-threatening.
Thousands of Yaz and Yasmin oral contraceptive users filed lawsuits against Bayer Healthcare for injuries and severe side effects caused by the medications. Bayer settled more than 4,800 blood clot lawsuits for over $1 billion and separately paid a $24 million lump sum settlement to as many as 8,000 Yaz and Yasmin users who developed gallbladder disease. Teva, manufacturer of Ocella oral contraceptive pills, was also the subject of a number of lawsuits for similar complaints.
Drospirenone/Ethinyl Estradiol Oral Contraceptives
|Yaz||drospirenone 3mg / ethinyl estradiol 0.02mg||Bayer Healthcare|
|Giavi||drospirenone 3mg / ethinyl estradiol 0.02mg|
|Loryna||drospirenone 3mg / ethinyl estradiol 0.02mg||Sandoz Pharmaceuticals|
|Nikki||drospirenone 3mg / ethinyl estradiol 0.02mg||Nurx Pharmaceuticals|
|Yasmin||drospirenone 3mg / ethinyl estradiol 0.03mg||Bayer Healthcare|
|Ocella||drospirenone 3mg / ethinyl estradiol 0.03mg||Teva Pharmaceuticals|
|Syeda||drospirenone 3mg / ethinyl estradiol 0.03mg||Sandoz Pharmaceuticals|
|Zarah||drospirenone 3mg / ethinyl estradiol 0.03mg||Mayne Pharma International|
|Beyaz||drospirenone 3mg / ethinyl estradiol 0.02mg / levomefolate 0.451mg||Bayer Healthcare|
|Safyral||drospirenone 3mg / ethinyl estradiol 0.02mg / levomefolate 0.451mg and levomefolate||Bayer Healthcare|
Drospirenone Birth Control Pills
Since 1960, most birth control pills have contained two types of hormones: estrogen and progesterone. Since 2001, some birth control pills have altered this tried-and-true formula by replacing the traditional form of progestin with a new and different synthetic hormone, called drospirenone.
Bayer was the first to introduce drospirenone and made big promises with this new ingredient. Not only would it protect against pregnancy like other birth control pills, it would also decrease acne, bloating and premenstrual depression. Upon releasing first Yasmin and later, Yaz, Bayer heralded it as the “one Pill that goes beyond the rest.”
Yaz Side Effects
Drospirenone presents a different set of health risks than other forms of birth control. In August 2009, the British Medical Journal (BMJ) published two studies showing that drospirenone, more than any other oral contraceptive, puts women at risk for developing serious blood clots. The Journal cited 40 cases of venous thrombosis, a severe kind of blood clot, including one that resulted in the death of a 17-year-old. The Dutch College of General Practitioners recommends that its members prescribe more traditional, non-drospirenone birth control pills rather than Yaz, Yasmin or Ocella.
Side effects which are unique to or worsened in drospirenone containing birth control pills include:
- Blood clot formation
- Deep vein thrombosis
- Pulmonary embolism
- Heart attack
- Gallbladder disease
Between 2004 and 2008, more than 50 deaths linked to Yaz and Yasmin were reported to the FDA.
Yaz and Yasmin Warnings
The Food and Drug Administration has issued several warnings to Bayer, the maker of Yaz and Yasmin. Warnings have been issued for false advertising, manufacturing issues and for safety reasons.
Bayer was accused of overstating the effectiveness of Yaz. The company claimed in advertising that it could be used for hormonal issues such as symptoms of PMS and to improve acne. In actuality, the drug is approved for the treatment of premenstrual dysphoric disorder (PMDD), a much more severe form of PMS and for moderate forms of acne. While medications can be given for unapproved or “off-label” uses, the company is not allowed to market them for anything other than approved indications.
Bayer was also accused of failing to adequately inform users of the risks of treatment. Ads featured rapid scene changes and loud background music which was proven to be distracting. Bayer was subsequently required to run advertising which corrected the misinformation. In 2009, the company was also warned for using low-quality batches of drospirenone from a plant in Germany.
Most importantly however, is the safety concerns that arose with all drospirenone oral contraceptive pills. The Food and Drug Administration has ordered that all birth control drugs carry a black box warning—the strongest warning the FDA can issue. A black box warning is included on all prescribing information at the top of the label. Yaz and other products with drospirenone boxed statement warning states that cigarette smoking may increase the chance for cardiovascular events, particularly in women over the age of 35.
Finding a Yaz Lawyer
Bayer has already settled thousands of cases for injuries caused by Yaz, Yasmin, Beyaz and Safyral. Other companies who make alternative forms of drospirenone oral contraceptives have also faced lawsuits. There have been no recent announcements regarding future lawsuit settlements, but past plaintiffs have received compensation for medical costs, pain and suffering and in some cases, punitive damages which are decided based on the injuries received.
Each case is unique and must be evaluated separately by an attorney who is an expert in Yaz legal claims.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.