Yaz, Yasmin & Ocella

Yaz^® (drospirenone/ethinyl estradiol)

Yasmin^® (drospirenone/ethinyl estradiol)

Ocella^® (drospirenone/ethinyl estradiol)

Common misspellings of the drug names include: Yas, Yasmine, and Yazmin

Yaz, Yasmin & Ocella Overview

Case Information

Federal Cases Consolidated by the Judicial Panel on Multidistrict Litigation (JPML) for the United States District Court for the Southern District of Illinois
MDL No. 2100

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.

The difference between Yaz, Yasmin, Ocella and other birth control pills on the market is that drospirenone, an ingredient in the product, has never before been marketed in the United States and is chemically unlike the other progestins available in the United States. Yaz, Yasmin, and Ocella have been marketed as safe as other available (non-drospirenone) contraceptives. As a result, many consumers of the drug have been injured. It is likely thousands of these women will either have a stroke, blood clot or undergo gallbladder surgery as a result of using Yaz/Yasmin.

Contact Us

Wexler Wallace LLP represents individuals who have suffered serious complications as a result of taking Yaz, Yasmin or Ocella.

If you or a loved one suffered serious injury from taking these medications, you may be eligible to file a claim. You are welcome to call us at (312) 346-2222 or complete our confidential online form. Your response will be reviewed by counsel and by Wexler Wallace nurse staff.

We also welcome inquiries from other counsel considering referring a case. We maintain significant relationships with other firms and counsel of the highest quality throughout the United States.

Brief Background of Oral Contraceptives

Shortly after the introduction of combined oral contraceptives 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 the pill.

As a result, new progestins were being developed, which became knows as "second generation" progestins (e.g. lovenorgestrel). 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 (e.g. gestodene and desogestrel) 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 contain the same estrogen component, ethinyl estradiol, that has been used in the lower dose birth control pills for decades. However, drospirenone is a new type of progestin and is considered a "fourth generation" progestin. No other birth control pills contain drospirenone, except for a recently approved generic version of the Yasmin and Yaz marketed under the name, Ocella (by Barr Laboratories, Inc.).

Since drospirenone in birth control is new, there are not decades of date available to support its safe use as there are with second generation progestins. Studies that were done prior to the FDA approval, however, indicate that drospirenone has certain effects that are different form those of traditional second generation progestins, and potentially more dangerous.

Failures Regarding Yasmin and Yaz

Bayer (and/or Bayer subsidiaries) market Yasmin and Yaz as providing the same efficacy as other birth control pills in preventing pregnancy, but with additional benefits. However, because Yasmin and Yaz contain the fourth generation progestin drospirenone, they present additional health risks not associated with other birth control pills.

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.

To view the 2003 FDA Warning Letter to Bayer, click here.

Indeed, 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 for the next six years.

Essentially, the pending complaints 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:

That Yasmin/Yaz is not as safe as other available contraceptives;
That the risks of adverse events with Yasmin/Yaz (drospirenone and ethinyl estradiol) were higher than those of other available contraceptives;
That the risks of adverse events with Yasmin/Yaz were not adequately tested and/or known by Defendants;
Plaintiff was put at risk of experiencing serious and dangerous side effects including, but not limited to, stress, pulmonary embolisms, heart attacks, gallbladder complications, as well as other severe and personal injuries, physical pain and mental anguish;
That patients needed to be monitored more regularly than normal while using Yasmin/Yaz;
That Yasmin/Yaz was designed, tested, manufactured, marketed, produced, distributed and advertised negligently, defectively, fraudulently and improperly.

During the brief time that Yasmin and Yaz have been sold in the United States, hundreds of reports of injury and death have been submitted to the FDA in association with the products.

Side Effects

Effects on Potassium Levels

Chemically, drospirenone causes an increase in potassium levels in the blood, if the potassium levels become too high, this can lead to a condition known as hyperkalemia. Hyperkalemia can cause various medical conditions, including hearth rhythm disturbances, such as extrasystolies, 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, or broken off pieces can travel to the lungs where they can cause pulmonary embolism, or can travel to the brain causing stroke.

Additionally, drospirenone is chemically related to spironolactone, a diuretic, which by nature works to combat hyperkalemia by working to rid 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.

Other Side Effects

Additionally, Yaz, Yasmin and Ocella have been connected to the following conditions:

Stroke
Kidney Failure
Pulonary Embolism
Deep Vein Thrombosis
Seizures & Convulsions
Gallbladder Problems
Blood Clots

Tell your healthcare professional about any side effect that bothers you or that does not go away.

This website is the property of Wexler Wallace LLP and is intended for informational purposes solely. Wexler Wallace LLP is not sponsored by, affiliated with, approved by, or endorsed by Bayer Schering Pharma (the manufacturer of Yaz^® and Yasmin^®) or Barr Laboratories, Inc. (the manufacturer of Ocella^®).