Yaz Thrombosis Lawsuit Joins MDL

Another Yaz thrombosis lawsuit has been filed over Bayer’s oral contraceptive, Yaz (drospirenone, ethinyl estradiol). The lawsuit was originally filed April 30, 2013 in the U.S. District Court, Northern District of New York (Syracuse). On August 19, 2013, the case was transferred to the Southern District of Illinois for inclusion in the multidistrict litigation (Yasmin and Yaz Marketing, Sales Practices, and Products Liability Litigation). An MDL is a federal procedure in which a  number of complex cases are combined for pre-trial processing to minimize strains on the court and duplicative processes.

This lawsuit alleges that the plaintiff’s use of Yaz/Yasmin placed her at significantly increased risk for serious side effects such as DVT (deep vein thrombosis), inter alia, heart arrhythmias, myocardial infarction, stroke and transient ischemic attack, embolisms, kidney disease, gallbladder disease, and sudden death. The complaint also alleges physical pain; mental anguish related to fear of developing these side effects; diminished enjoyment of life; potential high-risk pregnancies; an inability to use any prescription contraception; and the need for lifelong medical treatment, monitoring, and/or medications.

The plaintiff argues that the defendants did not provide adequate warnings to doctors, the health care community, and the general public about increased Yaz DVT risk. This Yaz thrombosis lawsuit seeks compensatory, punitive, exemplary and treble damages; interest; fees; and costs.

Yasmin received U.S. Food and Drug Administration (FDA) approval as a combination oral contraceptive in 2001; Yaz received approval as a combination oral contraceptive in 2006. Both contain nearly identical quantities of the progestrin, drospirenone, and the estrogen, ethinyl estradiol. Yaz/Yasmin differ from other birth control bills due to their being manufactured with the synthetic progestrin, drospirenone.

Yaz DVT risk and other side effects

In April 2002, following reports of 40 cases of venous thrombosis in women taking Yaz/Yasmin, the British Medical Journal reported that the Dutch College of General Practitioners recommended that older, second-generation birth control pills be prescribed instead of Yasmin. In February 2003, a paper entitled “Thromboembolism Associated with the New contraceptive Yaz/Yasmin” was published in the British Medical Journal and discussed a Netherlands Pharmacovigilance Centre report of additional reports of thromboembolism in which Yaz/Yasmin was the suspected culprit. The reports included two deaths. FDA Adverse Event data also reveal serious cardiac and sudden death reports tied to Yaz/Yasmin.

Yaz and Yasmin have been associated with at least 23 deaths in Canada, according to CBC News. Most women were under 26 years of age, according to Health Canada documents; the youngest was 14. The CBC reported that many of the deaths involved Yaz blood clots; some women died just weeks after initiating Yaz/Yasmin. For the most part, the women died suddenly, according to The Vancouver Sun.  Between 2007 and February 2013, medical professionals reported 600 cases of adverse reactions associated with Yaz/Yasmin use, including the 23 deaths, according to The Daily News. 

Bayer admonished for misleading marketing efforts

Meanwhile, Bayer has marketed Yaz/Yasmin as an effective treatment for premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), and moderate acne, in addition to its FDA-approved use as an oral contraceptive. Bayer promoted its blockbuster oral contraceptive as having fewer side effects, such as weight gain, bloating, and water retention that are typical in other pills. The defendants have been warned at least three times by the FDA—in 2003 2008, 2009—for misleading the public with television advertisements, that overstate the efficacy of Yaz/Yasmin, while minimizing its serious health risks.

This is not the first Yaz thrombosis lawsuit to be filed against Bayer Healthcare. Complaints continue to mount against the health care giant in the United States and Canada and Bayer has paid about $1.2 billion in Yaz lawsuit settlements, without admitting liability, according to The Vancouver Sun.