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Yaz®

This Litigation Has Concluded – MLG is Not Accepting New Cases

This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.

YAZ® is a FDA-approved pharmaceutical product "for the prevention of pregnancy" and "for the treatment of symptoms associated with premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception." YAZ®, YASMIN® and OCELLA® are combination oral contraceptives containing drospirenone and ethinyl estradiol. OCELLA® is the generic formulation of YAZ®/YASMIN®.

Progestin Drospirenone – Active Ingredient in YAZ® / YASMIN® / OCELLA®

YAZ® and YASMIN® contain the active ingredient progestin drospirenone which affects the body's normal balance of electrolytes and regulation of water (hydration). In particular, progestin drospirenone is thought to increase the levels of potassium, an essential electrolyte. Some theorize that this increase in potassium levels leads to dehydration which in turn results in an increased risk of developing blood clots.

Thromboembolic Risk Associated with YAZ® / YASMIN® / OCELLA®

Epidemiological studies demonstrate that the use of oral contraceptives is associated with a significantly increased risk of blood clots and related disorders/injuries. Two studies recently published in the prestigious British Medical Journal conclude that oral contraceptives that contain drospirenone (such as YAZ®/YASMIN®/OCELLA®) carry a significantly higher risk of developing venous thrombosis. In one study, the risk was 6.3 times greater for women using drospirenone-containing oral contraceptives than for women not using oral contraceptives.

The Increased Risk of Clotting and Related Disorders

The risk of blood clots and associated injuries/disorders is greater among users of oral contraceptives than it is among non-users. In the case of YAZ®/YASMIN®/OCELLA®, because they contain a pharmaceutical ingredient (progestin drospirenone) that increases potassium levels, some have theorized that this increases the risk of developing blood clots. Blood clotting can lead to such injuries as deep vein thrombosis, pulmonary embolism, heart attack and stroke. The risk of blood clots and serious cardiovascular side effects from the use of oral contraceptives is even greater among smokers. This additional risk increases with heavy smoking, particularly among women who are over 35 years of age.

Injuries Associated with Blood Clotting

Blood clotting creates blockages in the circulatory system. These blockages can hinder the normal flow of blood and thereby increasing the risk of heart attack (blood flow to heart is reduced) and stroke (blood flow to the brain is reduced). Blood clotting can also result in the release of a blood clot (embolus) into the circulatory system that can migrate to the lungs – a pulmonary embolism – that can also cause serious injury and death.

Misleading Television and Other Advertising

Both YAZ® and YASMIN® have been marketed to women through the use of television and other mass media advertising. In the case of each drug, the FDA has deemed much of the advertising as misleading because it understates the risks associated with the use of these oral contraceptives. Among others, the more serious is the risk of developing blood clots and related injuries.

Overstating Benefits and Understating Risks

In October 2008, the FDA issued a "Warning Letter" to Bayer Healthcare Pharmaceuticals, Inc., the manufacturer of YAZ®. In it, the FDA concluded that certain TV ads used by Bayer to promote the sale of YAZ® were misleading in that the content of the ads improperly broadened the indicated uses of YAZ®, overstated its efficacy and minimized the serious risks associated with its use.

YASMIN® has also been the subject of a "Warning Letter" issued by the FDA to its manufacturer. In the case of YASMIN®, the FDA concluded that the television advertising made implied claims that YASMIN® was superior to other combination oral contraceptives while, in the same ads, minimizing important risk information.

Corrective Action

In both cases, the FDA requested that the manufacturer cease the use of the advertising that was considered to be misleading about the risks and benefits of YAZ® and YASMIN®. In the case of YAZ®, the FDA requested that Bayer submit a comprehensive plan detailing the efforts Bayer would undertake to "disseminate truthful, non-misleading, and complete corrective messages" about the risks and benefits of YAZ®. In the face of legal action by the attorneys general of various states and the action by the FDA, Bayer agreed to spend $20million for corrective advertising.

This Litigation Has Concluded – MLG is Not Accepting New Cases

This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.

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