What are Yaz and Yasmin?
Yaz and Yasmin are two brand names of a popular contraceptive drug. Other generic brand names include Ocella, Gianvi, Loryna, Syeda, Vestura, and Zarah.
Whatever the brand name, this drug is a combination of drospirenone and ethinyl estradiol. These drugs work together to prevent pregnancy by preventing ovulation and changing the cervical and uterine lining. This both prevents an egg from becoming fertilized by sperm and also prevents an egg that somehow gets fertilized from being able to implant in the uterus.
Drospirenone is a synthetic progesterone hormone and ethinyl estradiol is a form of the hormone estrogen. The ratio of these two ingredients varies among the different brands. For instance, Yaz contains 3 mg of drospirenone and 30 mcg (0.03 mg) of ethinyl estradiol, while Yasmin contains 3 mg of drospirenone and only 20 mcg (0.02 mg) of ethinyl estradiol.
Yaz and Yasmin are also sometimes prescribed for acne or for premenstrual dysphoric disorder to treat symptoms like anxiety, depression, breast tenderness, lack of energy, and weight gain.
The developer and manufacturer of Yaz and Yasmin is the German-based pharmaceutical company Bayer.
What are the lawsuits about?
Bayer acknowledges that claimants allege having suffered personal injury, sometimes resulting in death of a loved one, after using their contraceptive drugs Yaz and Yasmin or their generic versions manufactured by other companies like Barr Laboratories, Inc. Bayer also acknowledges the investigations initiated by several State Attorneys General, one of whom has filed action alleging off-label promotion of the drug and failure to warn the public about the alleged increased risk of blood clots when using the drug.
In April 2012, the FDA reviewed independent studies and concluded that the drug combinations, particularly the use of drospirenone, used in Yaz, Yasmin and other generic brands “may be associated with a higher risk for blood clots than other progestin-containing pills.” The FDA mandated that the pharmaceutical companies list the information gleaned from these studies on the medication’s labeling. The FDA also mandated that they strengthen the written and advertised warnings of the risk of blood clots.
What is happening with the lawsuits?
Many lawsuits have been settled already through mass tort litigation. Bayer is positioning itself financially to pay for more settlements in the future.
According to Bayer’s Financial Statements in their 2013 Annual Report, as of February 10, 2014, there are 4,600 pending lawsuits and tort claims in the United States. This excludes any claims that had already been settled prior to February 2014. In Bayer’s previously settled claims, the company admitted no liability. These settlements paid 8,350 claimants over $1.69 billion.
In March 2013, another case was settled with no admission of liability. Under the settlement agreements, Bayer agreed to pay no more than $24 million for consumer gallbladder injuries alleged to be a result of Yaz or Yasmin. The settlement allots $2,000 to claimants who can demonstrate gallbladder injury and $3,000 to claimants who can demonstrate they required gallbladder removal surgery. As of February 10, 2014, over 8,800 claimants have filed to participate in this class action settlement.
Bayer ends its 2013 Annual Report by saying it anticipates more lawsuits will be filed. Bayer admits no wrongdoing in any of its settlement agreements.
Bloomberg reports that, as of August 2012, claimants were settling for an average of $212,000 per case.
What are the side effects?
The most dangerous side effects reported on both Yaz and Yasmin include:
Deep Vein Thrombosis (DVT)
The warnings in the drugs’ information sheet also list the following serious side effects that require emergency medical help:
- sudden numbness or weakness, especially on one side of the body;
- sudden and severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- a change in the pattern or severity of migraine headaches;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, tired feeling, mood changes).
Why haven’t these drugs been recalled?
Yaz was first introduced in the U.S. market in 2006. Yaz was the first contraceptive pill to use the synthetic hormone drospirenone.
By 2008, the FDA had cited Bayer 3 times for overstating the approved uses and understating the potential risks associated with the drug’s new form of synthetic hormone. The overstated claims included television advertising that claimed the drug helped with bloating, mood swings, and acne along with other unsubstantiated or unproven benefits.
In lieu of recalling the drug, the FDA has ordered Bayer to stop all advertisement of unapproved and unproven uses as well as to strongly warn potential users of the possibility of increased risks associated with drospirenone.
Although some of the studies examined by the FDA showed a risk 3 times greater than other birth control pills that did not include drospirenone, the FDA did not find this risk rose to the level of re-callable action. The FDA reasons, as does Bayer, that the risk of blood clots is higher in pregnancy and childbirth than in usage of drospirenone, so the drug is still safer than the pregnancy it prevents.
Instead of urging recall, the FDA is seeking to ensure Bayer educates consumers about the true risks and benefits so doctors and potential users can make an informed decision.
What about the other brand names of this drug?
Ocella, Gianvi, Loryna, Syeda, Vestura, and Zarah are other brands of contraceptive pills that use the controversial drospirenone synthetic hormone. These are not made by Bayer but use Bayer’s formula.
Generic drugs are manufactured by a different pharmaceutical company. Usually, the makers of a generic drug work with the original developer to produce an inexpensive version of the name brand original.
The FDA strictly regulates generic drugs. They must include the same active ingredients at the same dosage, although their inactive ingredients may vary. Generic drugs must undergo the same testing and prove just as effective as the original drug. Generic drug manufacturers are also required by the FDA to use the same labeling as the original drug, and they cannot make any changes to it.
Although there have been some lawsuits filed against the makers of these generic versions of Yaz and Yasmin, they face more difficulties in the courtroom. Because the generic drug makers did not develop the drug themselves and because they underwent the same FDA testing process as Bayer’s original, the generic drug makers are often found to have less or no liability for injuries and deaths.
This is sometimes known as the “generic drug loophole.” The precedent was set in the case Pliva v. Mensing, a 2011 Supreme Court case in which the Court found that generic drug manufacturers cannot be held liable for the lack of warnings on their labels. This, the Court argued, is because the FDA mandates that they not change the warning labels or chemical makeup of the original drug.
Further complicating matters, many insurance companies refused to cover Yaz or Yasmin. These insurance companies would require the patient to take a generic form. Such patients may have a more difficult legal case because of the “generic drug loophole.” Some states, like California, Vermont and Alabama, have made it easier for such patients to file a lawsuit against both the generic manufacturer and the original developer.
If you are considering taking Yaz, Yasmin or one of the generic versions of these drugs, ask your doctor for more information about the risks and benefits.
If you believe you or someone you know was injured by Yaz, Yasmin, or one of the generic versions of these drugs, consult with an attorney for information on filing a lawsuit or to make a claim as part of an existing class action settlement.