Some of the newest birth control pills -- Yaz, Yasmin, and Ocella -- are the subject of over 1,000 lawsuits that claim the medications increase the risk of blood clots and stroke and cause other health problems in women who take them. Litigation focuses on Bayer Healthcare's failure to disclose the risks of taking these fourth generation combination birth control pills. Recent research regarding Yaz and blood clots prompted the FDA to require Bayer to add warnings to the drug label. read on to learn more about these medications, health problems associated with them, and related legal action.
What Are Yaz, Yasmin, and Ocella?
Yaz, Yasmin, and Ocella are birth control bills that contain a new type of synthetic progestin called drospirenone. The drospirenone is combined with ethinyl estradiol to achieve the desired anti-pregnancy effect. These pills are called "fourth generation combination birth control pills." Other pills on the market, which use a different type of progestin, are called "second generation combination birth control pills."
Bayer Healthcare manufactures Yaz and Yasmin. Barr Laboratories manufactures Ocella.
The U.S. Food and Drug Administration (FDA) has approved Yaz, Yasmin, and Ocella to:
- prevent pregnancy
- treat premenstrual dysphoric disorder (PMDD), and
- treat moderate acne.
Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS) that affects between three and five percent of menstruating women. Symptoms include anger, irritability, markedly depressed moods, anxiety, bloating, change in appetite, headaches, and muscle aches. Yaz, Yasmin, and Ocella have not been shown to relieve regular PMS symptoms.
Health Problems Associated with Yaz, Yasmin, and Ocella
Drospirenone, the progestin used in Yaz, Yasmin, and Ocella, can cause increased blood levels of potassium. According to some scientists and doctors, the higher levels of potassium mean that the health risks associated with these drugs are higher than those associated with second generation birth control pills. Studies in Germany and Great Britain have found that health risks from taking Yaz, Yasmin, and Ocella are double those from taking other birth control pills. Those risks include:
- blood clots in the legs (called deep vein thrombosis)
- blood clots in the lungs (called pulmonary embolism)
- heart attack
- gall bladder disease
- pancreatitis, and
- death (usually as a result of a blood clot, stroke, or heart attack).
Some reports allege women have died as a result of Yaz-induced blood clots. Other women allege that because of a previous Yaz-induced blood clot, they may face other long-term side effects such as:
- pain in the area of the clot
- problems getting pregnant
- problems associated with taking blood thinners (which many clot victims must take), and
- an increased risk of developing a blood clot in the future.
FDA Warns Bayer on Yaz TV Ads
In 2008, the FDA sent a warning letter to Bayer, stating that Bayer's TV advertisements for Yaz had violated FDA rules. The FDA told Bayer that the ads were misleading because they suggested that Yaz would relieve PMS symptoms and help treat all types of acne, not just moderate acne. Bayer responded by pulling the ads from the air.
FDA Requires Label Change
In April 2010, the FDA required Bayer to include additional information on Yaz and Yasmin package inserts, regarding the risks of developing blood clots and stroke. Some consumer advocates say the label is still misleading since it cites Bayer-sponsored studies suggesting that Yaz does not pose a greater risk of developing blood clots than do second generation birth control pills.
Legal Theories in Yaz, Yasmin, and Ocella Lawsuits
More than 1,100 Yaz users or families of women who have taken Yaz have filed lawsuits across the country alleging that Yaz, Yasmin, and Ocella have caused harm. Many of the lawsuits' legal claims are grounded in product liability law.
In product liability cases, plaintiffs allege that they were harmed by a product because the product was defective. A defect can occur in the design, manufacture, or marketing of the drug. (To learn more about product liability claims in drug cases, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)
The Yaz, Yasmin, and Ocella lawsuits focus on Bayer's marketing of the drug, claiming that Bayer failed to adequately disclose the risks of taking Yaz in their advertisements and drug package inserts. Plaintiffs argue that Bayer should have informed doctors and patients that the risk of developing a blood clot or having a stroke while taking Yaz was much higher than if patients took the second generation birth control pill. If adequately informed of the risks, plaintiffs argue, doctors would have recommended that most women take the second generation birth control pills (and not Yaz, Yasmin, or Ocella) and that most women, having received the information about side effects, would have chosen the second generation pill over Yaz.
Plaintiffs also allege that Bayer and Barr Laboratories did not fully disclose their research on the side effects of Yaz, Yasmin, and Ocella to the FDA.
Federal Multidistrict Litigation
In October 2009, the federal court system consolidated all of the federal Yaz, Yasmin, and Ocella cases from around the country into one case, called the multidistrict litigation (MDL). In multidistrict litigation, cases involving similar issues of fact are transferred to one court for pretrial and discovery proceedings (the process where each side finds out everything they can about the other side's case). The MDL is now in the U.S. district court of the Southern District of Illinois and the presiding judge is U.S. District Court Judge David R. Herndon. Judge Herndon has the power to dismiss some or all of the claims and to approve settlements. If the cases don't settle, they will be sent back to the original court of filing for trial. (To learn more about multidistrict litigation, see Nolo's article Multidistrict Litigation (MDL) for Drug and Other Lawsuits.)
Consolidation of State Lawsuits
Hundreds of plaintiffs from around the country have filed Yaz, Yasmin, and Ocella lawsuits in state courts. In some of those states, like New Jersey and Pennsylvania, the state court system has consolidated the lawsuits into one lawsuit for case management and discovery purposes.
The legal and medical issues in Yaz, Yasmin, and Ocella cases are usually sophisticated and complex. Depending on the circumstances of your case, you may want to hire a lawyer who specializes in products liability litigation (or, even better, one who has experience with pharmaceutical cases). You may also consider joining an existing class action lawsuit, if there is one. (To learn more about class actions, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.) For help on choosing a good personal injury attorney, read Nolo's article Finding a Personal Injury Lawyer or visit Nolo's Lawyer Directory for a list of personal injury attorneys in your geographical area.