Yaz, Yasmin and Ocella
Court: United States District Court for the Southern District of Illinois (Consolidated by Judicial Panel on Multidistrict Litigation)
Case No.: MDL No. 2100
Wexler Wallace represents individuals who have suffered serious complications as a result of taking Yaz, Yasmin, or Ocella, which are oral contraceptives containing a relatively new “fourth generation” progestin called drospirenone, in combination with the ethinyl estradiol, an estrogen. In the short time Yaz, Yasmin and Ocella have been sold in the United States, the FDA has received hundreds of reports of injury and death associated with the products. Among the most common problems has been increased thrombosis formation. The FDA has criticized the manufacturer of Yaz and Yasmin, for overstating the efficacy of the drugs while minimizing their serious risks and has required the manufacturer to run corrective advertisements.
While many oral contraceptives combine progestin and estrogen, none – other than Yaz, Yasmin and Ocella – use drospirenone. Plaintiffs allege that Bayer, manufacturer of Yaz and Yasim, ignored the correlation between the use of Yasmin and Yaz and increased thrombosis formation and other serious side effects. Plaintiffs further allege that Bayer has marketed the drugs fraudulently by failing to fully disclose the risks of the drugs. Plaintiffs have also sued Barr Laboratories, which sells the generic version of Yaz, for similar violations. Plaintiffs believe that thousands of women have suffered or could suffer serious health complications from taking these drugs.
The products at issue in this litigation are:
- Yaz® (drospirenone/ethinyl estradiol)
- Yasmin® (drospirenone/ethinyl estradiol)
- Ocella® (drospirenone/ethinyl estradiol)
Common misspellings of the drug names include Yas, Yasmine, and Yazmin. Yaz and Yasmin are oral contraceptives developed, designed, licensed, and manufactured by Bayer and/or Bayer subsidiaries. Ocella is the generic version of Yaz and Yasmin and is a registered trademark of Barr Laboratories, Inc.
These products utilize what is know as the “fourth generation” of progestins used in combined oral contraceptives (combining progestins and estrogens). Shortly after the initial introduction of combined oral contraceptives – also known as birth control pills – in the 1960s, doctors and researchers found that women using birth control pills had a higher risk of blood clots, heart attacks and stokes than women not using birth control pills.
To lower those risks, new progestins were developed for use in oral contraceptives. These “second generation” progestins, when combined with the lower amounts of the estrogen ethinyl estradiol helped to reduce the risk of blood clots, heart attacks and strokes and were considered safer for women. During the 1990s, new “third generation” progestins were developed. Unfortunately, these “third generation” progestins have been associated with a greater risk of blood clots in the deep veins (deep vein thrombosis or “DVT”) and lungs (pulmonary embolism or “PE”). As a result of this increased risk of blood clots, the FDA has required that products containing third generation progestins include a warning of the potentially increased risk of thrombosis.
Yasmin, Yaz, and Ocella use a “fourth generation” progestin – drospirenone. Indeed, they are the only birth control pills to use this progestin. As drospirenone in birth control is new; there is far less data to support its safe use as there is for second generation progestins. Studies that were done prior to the FDA approval, however, indicate that drospirenone has certain side effects that are different from traditional second generation progestins, and is potentially more dangerous.
Potential Side Effects
Effects on Potassium Levels
Drospirenone causes an increase in potassium levels in the blood. If potassium levels become too high, this can lead to a condition known as hyperkalemia. Hyperkalemia can cause various medical conditions, including heart rhythm disturbances, such as extrasystoles, or pauses of bradycardia. If left untreated, hyperkalemia can be fatal. If hyperkalemia disrupts the normal hearth rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form, including deep vein thrombosis. Blood clots in the heart can then lead to heart attacks. Broken off clots can travel to the lungs where they can cause pulmonary embolism or travel to the brain causing stroke.
Additionally, drospirenone is chemically related to spironolactone, a diuretic, which by nature works to combat hyperkalemia by ridding the body of the excess potassium levels. In patients without elevated potassium levels, drospirenone can cause hypokalemia due to potassium deficiency. Hypokalemia can cause complications with the gallbladder, cardiovascular system, and renal functions (to name a few) potentially leading to surgery or organ failure.
Yaz, Yasmin and Ocella have been connected to the following conditions:
- Kidney Failure
- Pulmonary Embolism
- Deep Vein Thrombosis
- Seizures & Convulsions
- Gallbladder Problems
- Blood Clots
Failures Regarding Yasmin and Yaz
Shortly after Yaz, Yasmin and Ocella went on the market in the United States, the FDA began receiving reports of side effects and injuries. In 2003, 2008, and 2009, the FDA warned Bayer against misleading the public through the use of ads which overstate the efficacy of Yaz and/or its predecessor Yasmin while minimizing the serious risks associated with the drug. For the FDA Warning Letters to Bayer in 2003 click here, 2008 click here, and 2009 click here.
The FDA felt the over-promotion of Yaz was so severe that it required Bayer to run new TV advertisements to correct the previous misleading Yaz advertisements.
Bayer ultimately agreed to spend at least $20 million on corrective TV advertisements and to submit all Yaz advertisements to the FDA for advanced screening in the next six years.
Plaintiffs allege that Bayer ignored the correlation between the use of Yasmin and Yaz and increased thrombosis formation despite the wealth of the scientific information available. Many of the complaints allege the following false marketing/issues with the drug:
- Defendants failed to inform consumers that Yasmin/Yaz is not as safe as other available contraceptives;
- Defendants failed to inform consumers that the risks of adverse events with Yasmin/Yaz were higher than those of other available contraceptives;
- Defendants failed to inform consumers that the risks of adverse events with Yasmin/Yaz were not adequately tested and/or known by Defendants;
- Defendants put Plaintiffs at risk of experiencing serious and dangerous side effects including, but not limited to, stress, pulmonary embolisms, heart attacks, and gallbladder complications, as well as other severe and personal injuries, physical pain, and mental anguish;
- Defendants failed to inform consumers that patients needed to be monitored more regularly than normal while using Yasmin/Yaz;
- In designing, testing, manufacturing, marketing, producing, distributing and advertising Yasmin/Yaz, Defendants acted fraudulently and improperly.
Wexler Wallace also welcomes inquiries from other counsel considering referring a case with respect to Yaz, Yasmin, or Ocella injuries. We maintain significant relationships with other firms and counsel of the highest quality throughout the United States.
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