Practice Areas Mass Torts (Dangerous Drugs) Paragard

Yaz and Yasmin

Yaz and Yasmin are two brand names of a widely used birth control drug. They are also sometimes prescribed for acne or premenstrual dysphoric disorder to treat symptoms such as anxiety, depression, breast tenderness, weight gain, and fatigue. The German pharmaceutical company, Bayer, produces Yaz and Yasmin. Other generic names for Yaz and Yazmin include:

• Ocella
• Gianvi
• Loryna
• Syeda
• Vestura
• Zarah

Claimants have allege having suffered serious injury, sometimes resulting in death, after using the contraceptive drugs Yaz and Yasmin or their generic versions created by other companies. Bayer acknowledges several investigations initiated by State Attorneys General. One State Attorney General has filed action against Bayer alleging off-label promotion of the drugs and failure to warn consumers about the increased risk of blood clots when using the drugs.

The Food and Drug Administration reviewed various independent studies in 2012 and concluded that the drug combinations used in Yaz, Yasmin, and their generic brands could be linked to higher risk for blood clots than other contraceptive pills. The FDA has since mandated that pharmaceutical companies clearly list the information from these independent studies on their label, and that they strengthen the written and advertised warnings of blood clots.

The most dangerous side effects of Yaz and Yasmin include:

• Blood Clots
• Heart Attack
• Stroke
• Deep Vein Thrombosis
• Pulmonary Embolism
• Death

Warnings found within the drugs’ information sheet state the the following serious side effects require immediate 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;
• Swelling in hands, ankles, or feet;
• A breast lump; or
• Symptoms of depression

Yaz was first introduced to the United States market in 2006 and was the first contraceptive pill to use the artificial hormone drospirenone. After only two years on the market, Bayer was cited three times by the FDA for exaggerating the approved uses and downplaying the potential side effects associated with using the drug. Advertisements claimed that the drug helped treat bloating, mood swings, an acne along with other unproven benefits. The FDA has since ordered Bayer to stop advertising unsubstantiated claims but reasoned that the risks of the drug were not grounds for recall.

A different pharmaceutical company makes the generic forms of Yaz and Yasmin, but they use Bayer’s formula. The FDA strictly regulates generic drugs. They must include the same active ingredients at the same dosage. Their inactive ingredients may vary. Generics undergo the same testing to prove just as effective as the original. Manufacturers of generic drugs are also mandated to use the same labeling as the original drug and are not allowed to alter the label in any way.

Lawsuits against generic drug manufacturers face more difficulty in the courtroom. The generic drug manufacturers did not develop the drugs themselves, and they underwent the same FDA testing process as the original. As a result, the generic drug manufacturers are often found to have little or no liability for injuries and deaths. This is called the generic drug loophole. A 2011 supreme court case ruled that generic drug makers cannot be held liable for the lack of warnings on their label because the FDA does not allow them to alter the labels or chemistry of the original drug.

If you are considering taking Yaz, Yasmin, or one of their generic versions, ask your physician about the potential risks and benefits. If these drugs injured you or someone you know, consult the law offices of John Michael Bailey right away for information on filing an individual lawsuit or joining an existing class-action lawsuit.

Sources:

http://cir.ca/news/scotus-generic-drugmaker-liability-case

http://www.reuters.com/article/2009/10/21/idUS204695+21-Oct-2009+BW20091021

http://www.drugs.com/yaz.html

http://www.drugs.com/cdi/drospirenone-ethinyl-estradiol.html

http://www.fda.gov/drugs/drugsafety/ucm299305.htm

http://www.annualreport2013.bayer.com/en/legal-risks.aspx

http://www.drugwatch.com/yaz/recall.php