According to a report issued by Bayer last week, the drug maker has settled Yaz side effect lawsuits filed by 651 plaintiffs in the United States, agreeing to pay about $142 million or an average of $218,000 per claim. The drug firm has indicated however, that it is only settling lawsuits for venous clot injuries, including pulmonary embolism and deep vein thrombosis (DVT), at this time. The information was included in the “Legal Risks” section of Bayer’s First Quarter 2012 Stockholder’s newsletter, confirming recent reports that Bayer had begun to resolve some lawsuits associated with its potentially dangerous birth control pills.
SIDE EFFECT RISKS OF YAZ AND YASMIN
Even in the face of reported agreements to resolve some lawsuits for blood clot injuries, product liability lawsuits continue to be filed against Bayer by an estimated 14,000 patients throughout the country who used the company’s Yaz, Yasmin, Ocella and Gianvi birth control pills. The complaints involve a variety of injuries allegedly linked to the oral contraceptives, including heart attacks, strokes, deep vein thrombosis, pulmonary embolism, gallbladder disease, and other complications possibly caused by side effects of the drospirenone-containing birth control pills.
Serious concerns have been raised about Yaz and other oral contraceptives containing drospirenone, a synthetic progestin used in combination with estrogen to prevent pregnancy in women. In fact, the FDA recently announced its decision to update warning labels for Yaz, Yasmin and other drospirenone-containing birth control pills, to notify patients about the potential risk of blood clots, which can lead to life-threatening complications. Deep vein thrombosis involves a blood clot that occurs in the deep veins of the leg or pelvis. A pulmonary embolism occurs when a blood clots breaks free and travels through the bloodstream to become lodged near the lung.
BAYER FACES YAZ LAWSUITS FOR BLOOD CLOT SIDE EFFECTS
Bayer has indicated that it is only resolving lawsuits involving DVT or pulmonary embolism injuries, and only after conducting a case-specific analysis of medical records on a rolling basis. According to Bayer, the exact number of Yaz pulmonary embolism and DVT lawsuits that remain unresolved is unclear at this time, but the firm has indicated that less than half of complaints allege such an injury. As estimates provided in court records in October 2010 suggest, 40% to 41% of Yaz lawsuits involved pulmonary embolism or DVT, while 10% of cases involved heart attack or stroke side effects, and about 43% involved claims for gallbladder complications.
The first trial for Yaz side effects was scheduled to begin on January 9, 2012, although the trial was postponed less than two weeks before the determined start date, and the parties were ordered to engage in negotiations to settle the Yaz lawsuits. Bayer has reported to stockholders that the company has taken appropriate accounting measures for anticipated defense costs and for potential future settlements based on the information currently available. According to information provided by the FDA, between three and nine out of 10,000 women taking Yaz or Yasmin could develop a blood clot in any given year, compared to between one and five out of 10,000 women who do not take a drospirenone-containing oral contraceptive.