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Yaz, Yasmin Lawsuits May Become Class Action in New Jersey

Posted by Jane Akre
Wednesday, November 11, 2009 12:55 AM EST
Category: Major Medical
Tags: Yaz, Yasmin, Ocella, MDL, Class Action, Bayer HealthCare Pharmaceuticals, Teva Pharmaceuticals, FDA, Heart Attack, Stroke, Gallstones, Oral Contraceptives

Thousands of cases may eventually be filed against Bayer over its Yax and Yasmin oral contraceptives.

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IMAGE SOURCE: KGO-TV San Francisco Web site/ image of Susan Galinis

In 2007, Susan Galinis, of the San Francisco area, was the happy mother of three-year-old twins.

Wanting to have more children later she choose an oral contraceptive, but four weeks and one day after she began taking Yaz, she had a stroke.

Surgeons had to remove part of her skull as her brain was swelling and the stroke caused brain damage.

She has been told her IQ is 77, she is in chronic pain and has no short term memory.

Her twins have had to cope with the help of a counselor with not seeing their mother for six months while she was in the hospital. He doctors say that Yaz caused her stroke. She is suing drug maker Bayer HealthCare Pharmaceuticals.

In fact, there are so many lawsuits coming into New Jersey over Yaz and its sister contraceptive, Yasmin, that the New Jersey judiciary is considering forming a mass tort case against Bayer, located in Wayne, New Jersey.

Courthouse News Service reports that Bayer is facing more than 125 lawsuits over Yaz and up to six new cases a day are being filed around the country. Lawyers predict there could be 1,000 cases filed in the state.

The cases have been filed against Bayer, maker of Yaz and Yasmin, and Teva Pharmaceuticals, which makes the generic version, Ocella.

Yaz is the newest sister to drug Yasmin, approved in 2001. Yaz, approved in 2006, contains less estrogen. They are considered the go-to drugs for women under the age of 35, and generated sales of about $1.8 billion for Bayer last year.

All three oral contraceptives are among the most widely used and involve a combination of ethinyl estradiol with drospirenone. It has been linked to health problems including strokes, heart attacks, deep vein thrombosis, gallbladder disease, pulmonary embolisms and death.

Bayer says its studies, which it financed, find cardiovascular risks among women on the Bayer products were comparable to an older formula of birth control pills and that patient safety is its top priority.

Buy Bayer’s credibility was questioned when the company received an FDA letter that it had to retract misleading television commercials that the FDA said overstated the drug’s efficacy and promoted it to relieve premenstrual syndrome, for which it is not approved. Bayer says it spent $20 million on the retraction.

Then in August, the FDA said Bayer did not follow proper quality control procedures in its drug making plant.

The allegations of increased risk for blood clots and other adverse events associated with Yasmin/Yaz birth control are similar to those made against two other popular birth control devices, namely Nuvaring by Schering-Plough and the Ortho Evra patch, by Johnson and Johnson. However, Yasmin/Yaz has also been linked to gallbladder problems.

Symptoms of gallbladder problems can include pain or discomfort in the upper right side of the abdomen, nausea, diarrhea, bloating and jaundice. Blood clots can cause sudden severe headaches, swelling in the legs or arms, a crushing chest pain or coughing blood as well as blurred vision.

Federal Yaz litigation has already been consolidated for pretrial proceedings in an MDL or multidistrict litigation in East St. Louis. Pennsylvania state court is consolidating the Yasmin and Yaz lawsuits in Philadelphia.

The New Jersey courts will accept comments from the public until December 31 on consolidating the cases. #


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